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. 

Not as much was said at the press briefing about the specifics of the Final Rule on Meaningful Use as was said about the important role that electronic health records (EHRs) will play in health care reform.  Sebelius emphasized that implementation of EHRs will help move Americans into a 21st century health care system, where patients and doctors take control of their health information.  Sebelius said that EHRs are the foundation of a high performing, high quality, health care system. “When implemented meaningfully and effectively,” said Sebelius, “EHRs will serve to reduce errors, lower cost, and increase patient and doctor satisfaction.”  Just as Americans can readily access their bank accounts, HIT promises to bring the same transformation of consistency and reliability to one’s personal health information, Sebelius said.

Secretary Sebelius noted that only 20% of doctors and 10% of hospitals even use “basic” EHRs.  Sebelius said that modifications to the Final Rule, made after considering over 2,000 comments to the Proposed Rule released at the end of  December 2009, should help remove barriers and give doctors the flexibility they need to find their own path to implementation of an EHR. Sebelius then turned the podium over to Dr. Berwick. 

Dr. Berwick said he liked the phrase “meaningful use” and asked himself, “Meaningful to whom?” The answer, he said, is that it must be meaningful to those providing the care and to the patient.  He discussed his personal experiences with EHRs, feeling that he had been “spoiled” because he had grown up practicing medicine in an organization that had implemented EHRs early on, the Harvard Community Health Plan.  He saw first hand the benefits of the EHR. He also noted that moving from paper to an EHR is hard and can be awkward. However, he said, “once we get through the awkwardness of the change process,” our health care delivery system is going to be “safer, smoother, more collaborative, with more teamwork, more efficient, and will reduce cost.”

Dr. Blumenthal, introduced by Secretary Sebelius as “the tireless leader” of this effort, then spoke about his personal experiences with HIT.  He said, “The reason I’m here today is because as a physician of a certain age, I was forced to use an EHR, and I saw it make my care better before my eyes.”  He said that he believes the small victories in avoiding errors and duplicative services (such as x-rays), when spread across the health care system, will have enormous benefits and ultimately will make physicians more comfortable in their roles.  Dr. Blumenthal said that the Final Rule on Meaningful Use is intended to address the financial barriers to getting the $44,000 incentives to physicians for EHR adoption. The Final Rule on Standards & Certification Criteria is intended to address the logistical and technical barriers and ensure that EHRs are capable of meeting meaningful use.  Dr. Blumenthal noted the recent release of the proposed rule to increase the privacy and security of EHRs and said that these Final Rules have privacy and security requirements built into the meaningful use matrix.  “We realize that we have to have the trust of the American people for this to work the way we know it can.” He closed with saying, “Using clinical information is a core competency. We are only as good as the information we have.”

Dr. Benjamin then discussed her personal experiences during catastrophes faced by a physician without an EHR and how those situations persuaded her to implement an EHR in her small solo practice in Viola, Alabama. She talked about facing a loss of paper records during two hurricanes that destroyed her clinic. The final blow was the destruction of her clinic on New Year’s Eve just after a grand opening of a new clinic built after the last hurricane.  Her staff made her promise that they never again would have to worry about using waterproof ink and drying sheets of paper in the sun. She always thought she could not find the money for an EHR but the donation of $7 from a child to help rebuild her clinic after the fire convinced her that money could no longer be an excuse.  She said, “I realized now that I couldn’t afford not to have an EHR.”

In answer to a question posed from the audience about the increased flexibility offered in the Final Rule on Meaningful Use, Dr. Blumenthal responded, “We heard two consistent things in the comments we received to the proposed rule, that it’s an all or nothing proposition and that it’s too inflexible.”  Accordingly, said Dr. Blumenthal, the rule reduces the number of core objectives.  There are 15 objectives for Eligible Professionals and 14 for Eligible Hospitals. There are an additional 10 objectives on an “ala carte” menu from which EPs and hospitals choose five more objectives.  The Final Rule also reduces achievement levels for several of the objectives. For example, instead of EPs being required to achieve 75% in electronic prescriptions, this has been reduced to 40%.  The total number of quality measures were reduced and certain quality measures were deferred to Stages II or III.

For the government’s press release on the release of the two rules, click here. For more information from ONC about the Meaningful Use rule, click here.  The CMS webpage dedicated to EHR incentive programs, with links to the Rules and FAQs, is available here.  Update: The Finals Rules were published in the Federal Register on July 28, 2010.