CMS, ONC propose meaningful use definition, EMR incentive program

The Centers for Medicare & Medicare Services (CMS) and the Office of the National Coordinator for Health IT (ONC) are encouraging public comment on the two regulations issued Dec. 30 that lay a foundation for meaningful use of certified EHR technology. The regulations will help implement the EHR incentive programs enacted under the American Recovery and Reinvestment Act of 2009 (ARRA).

A proposed rule issued by CMS outlines proposed provisions governing the EHR incentive programs, including defining the central concept of meaningful use of EHR technology. An interim final regulation (IFR) issued by ONC sets initial standards, implementation specifications and certification criteria for EHR technology. Both regulations are open to public comment.

“Widespread adoption of EHRs holds great promise for improving health care quality, efficiency and patient safety,” said National Coordinator for Health IT David Blumenthal, MD, during a media call on the regulations. “Over time, we believe the EHR incentive program under Medicare and Medicaid will accelerate and facilitate health IT adoption by more individual providers and organizations throughout the healthcare system.”

“These regulations are closely linked,” said Charlene Frizzera, CMS acting administrator. “CMS’ proposed regulation would define and specify how to demonstrate ‘meaningful use’ of EHR technology, which is a prerequisite for receiving the Medicare incentive payments. Our rule also outlines the proposed payment methodologies for the Medicare and Medicaid EHR incentive programs. ONC’s regulation sets forth the standards and specifications that will enhance the interoperability, functionality, utility and security of health information technology.”

During the media call, Jonathan Blum, director of the Center for Medicare Management, said the proposed regulation seeks to harmonize requirements across Medicare Fee for Service, Medicare Advantage and Medicaid. "CMS and ONC believe that it’s critical to be as consistent as possible but we also recognize that these programs are different and some flexibility is warranted," said Blum.

“This is a proposed regulation," he said. "CMS and ONC will carefully consider all comments received."

CMS and ONC reportedly worked to develop the two rules and received input from hundreds of technical subject matters experts, healthcare providers, and other key stakeholders. Numerous public meetings to solicit public comment were held by three federal advisory committees: the National Committee on Vital and Health Statistics, the Health IT Policy Committee and the Health IT Standards Committee (HITSC). HITSC presented its final recommendations to the National Coordinator in August. These recommendations, along with all other input were considered to help inform the development of the regulations announced last week, according to the agencies.

The IFR issued by ONC describes the standards that must be met by certified EHR technology to exchange healthcare information among providers and between providers and patients. This initial set of standards begins to define a common language to ensure accurate and secure health information exchange across different EHR systems. The IFR describes standard formats for clinical summaries and prescriptions; standard terms to describe clinical problems, procedures, laboratory tests, medications and allergies; and standards for the secure transportation of this information using the Internet.

The IFR is calling for the industry to standardize the way in which EHR information is exchanged between organizations, and sets forth criteria required for an EHR technology to be certified. These standards will support meaningful use and data exchange among providers who must use certified EHR technology to qualify for the Medicare and Medicaid incentives.

Under the statute, The Department of Health and Human Services was required to adopt an initial set of standards for EHR technology by Dec. 31. The IFR will go into effect 30 days after publication, with an opportunity for public comment and refinement over the next 60 days. A final rule will be issued in 2010.  “We strongly encourage stakeholders to provide comments on these standards and specifications,” Blumenthal said.

The ARRA established programs to provide incentive payments to eligible professionals and eligible hospitals participating in Medicare and Medicaid that adopt and make meaningful use of certified EHR technology. Incentive payments may begin as soon as October 2010 to eligible hospitals, said the proposed rule. Incentive payments to other eligible providers may begin in January 2011.

"When we began to consider how to proceed shortly after the passage of ARRA, we made a critical decision, which we [think] is reflected consistently in the proposed rules, to align Medicare and Medicaid to the fullest extent possible," said Cindy Mann, director of the Center for Medicaid and State Operations, during the media call. The intent is "to foster coordinated systems and to support the efforts of ONC around certification and standards," said Mann. "We aligned meaningful use definitions to a large degree."

The proposed rule would define the term ‘meaningful EHR user’ as an eligible professional or eligible hospital that, during the specified reporting period, demonstrates meaningful use of certified EHR technology in a form and manner consistent with certain objectives and measures presented in the regulation. These objectives and measures would include use of certified EHR technology in a manner that improves quality and safety of healthcare delivery, reduces healthcare disparities, improves care coordination, improves population and public health and ensures adequate privacy and security protections for personal health information.

The proposed rule would define meaningful use for the Medicare EHR incentive programs. It proposes one definition that would apply to eligible professionals participating in the Medicare fee-for-service and the Medicare Advantage EHR incentive programs as well as a proposed definition that would apply to eligible hospitals and critical access hospitals. The definitions also would serve as the minimum standard for eligible professionals and eligible hospitals participating in the Medicaid EHR incentive program. The rule proposes that states could request CMS approval to implement additional meaningful use measures, as appropriate, but could not request approval of fewer or less rigorous meaningful use measures than required by the rule.

This rule proposes a phased approach to implement the proposed requirements for demonstrating meaningful use. The approach would initially establish reasonable criteria for meaningful use based on currently available technological capabilities and providers’ practice experience. CMS will establish stricter and more extensive criteria for demonstrating meaningful use over time, as anticipated developments in technology and providers’ capabilities occur.

CMS is providing a 60-day comment period on the proposed rule.

“The definition and requirements for demonstrating meaningful use of EHR technology are proposals. CMS welcomes and will give serious consideration to comments that improve our proposal while achieving the goals Congress established for the EHR incentive programs,” Frizzera said.

In early 2010 ONC said it intends to issue a notice of proposed rulemaking related to the certification of health IT.

The CMS proposed rule and fact sheets, may be viewed at http://www.cms.hhs.gov/Recovery/11_HealthIT.asp.

ONC’s interim final rule may be viewed at http://healthit.hhs.gov/standardsandcertification.

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