Health IT Law Blog : Health IT Law Blog : Post & Schell: Law Firm : HIT & Electronic Health Records

Via NIST:

In efforts to help the nation's health care industry make the transition to the digital age in an effective and meaningful fashion, the National Institute of Standards and Technology (NIST) has published a set of approved procedures for testing information technology systems that work with electronic health records (EHRs). Released in draft form earlier this year (see "NIST, Partners Develop Testing Infrastructure for Health IT Systems," NIST Tech Beat for March 16, 2010, at http://www.nist.gov/itl/hit_031610.cfm), the approved and finalized testing procedures are now available for use.

Under a certification program established by the U.S. Department of Health and Human Services Office of the National Coordinator (HHS/ONC), testing organizations authorized by HHS/ONC can use the tools to evaluate EHR software and systems that vendors would like to sell to doctor's offices, hospitals and other health care providers. Starting next year, the federal government will provide extra Medicare and Medicaid payments to health care providers that implement EHR systems certified to meet ONC requirements that conform to technical standards and are put to "meaningful use," performing specifically defined functions.

These ONC-approved test procedures help ensure that electronic health records function properly and work interchangeably across systems developed by different vendors. The set of 45 approved test procedures evaluate components of electronic health records such as their encryption, how they plot and display growth charts, and how they control access so that only authorized users can access their information.

The development of these tools was mandated by the American Recovery and Reinvestment Act (ARRA) in order to support a health IT infrastructure.

Notice of the approved test procedures appears in the August 9, 2010, Federal Register. For more information, see http://healthcare.nist.gov/use_testing/finalized_requirements.html and http://healthit.hhs.gov/certification
 

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In a letter to Dr. David Blumenthal, the College of Healthcare Information Executives (CHIME), an organization which represents1,400 healthcare chief information officers, offered some criticism of ONC's recent notice of proposed rulemaking (NPRM) regarding the EHR certification program.  While CHIME expressed general support for a two-stage approach for creating the certifying bodies, the CIO's are worried about any destabilizing effects such rule may have on the health IT market.  Via Healthcare IT News:

We are very concerned that the introduction of a two-stage approach for certification will prolong the current instability in the health IT marketplace, which exists because of the un-finalized status of meaningful use and certification regulations," CHIME wrote. "The introduction of two separate certification schemes – one temporary and one permanent – carries a risk of continuing the uncertainty and promoting needless product replacement in the marketplace.

CHIME issued a few recommendations to combat such uncertainty, which you can find after the jump.

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• Javelin Strategy & Research survey found over 275,000 cases of medical identity theft in 2009, with an average price tag greater than $12,000 per incident.  This is twice as many cases as in 2008.  Keeping health information safe is going to be of paramount importance in the next decade, especially considering the steep rise in use of electronic health records. According to Computerworld.com (citing a study by IDC, a research firm), "about a quarter of all Americans -- 77 million people -- already have an EHR, up from 14% from in 2009." By 2015, experts believe the number will reach up to 60%, partially due to the transformation of the health IT industry by the HITECH Act.

• In its comments to CMS regarding the meaningful use NPRM, College of Healthcare Information Management Executives (CHIME) insisted that the present "all or nothing" approach to achieving meaningful use is going to prevent significant numbers of eligible providers from receiving any incentive payments under the HITECH Act.  According to American Medical News:

Among CHIME's suggestions: a gradual implementation process that would allow physicians to qualify for incentives by achieving 25% of meaningful use objectives by 2011, 50% by 2013, 75% by 2015, and 100% by 2017.

'Without an approach that rewards progress or provides sufficient time, organizations with limited resources will likely have little chance of qualifying for payments, thus widening the 'digital divide' in the country,' CHIME wrote.

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ONC announced release of the much-anticipated Notice of Proposed Rulemaking (NPRM) on certification programs.  Via ONC Press Release:

Certification of Health IT will provide assurance to purchasers and other users that an EHR system, or other relevant technology, offers the necessary technological capability, functionality, and security to help them meet the meaningful use criteria established for a given phase. Providers and patients must also be confident that the electronic health IT products and systems they use are secure, can maintain data confidentially, and can work with other systems to share information. Confidence in health IT systems is an important part of advancing health IT system adoption and allowing for the realization of the benefits of improved patient care.

Eligible professionals and eligible hospitals who seek to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs are required by statute to use Certified EHR Technology. Once certified, Complete EHRs and EHR Modules would be able to be used by eligible professionals and eligible hospitals, or be combined, to meet the statutory requirement for Certified EHR Technology.
 

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CMS released a proposed rule pursuant to the HITECH Act which includes the much-anticipated definition of Meaningful Use of Certified EHR technology.  You can find the full text here.*

HHS has also released an interim final rule with a request for comments to adopt an initial set of standards, implementation specifications, and certification criteria, as required by section 3004(b)(1) of the Public Health Service Act. This interim final rule represents the first step in an incremental approach to adopting standards, implementation specifications, and certification criteria to enhance the interoperability, functionality, utility, and security of health information technology and to support its meaningful use. The certification criteria adopted in this initial set establish the capabilities and related standards that certified electronic health record (EHR) technology will need to include in order to, at a minimum, support the achievement of the proposed meaningful use Stage 1 (beginning in 2011) by eligible professionals and eligible hospitals under the Medicare and Medicaid EHR Incentive Programs.  You can find this interim rule here.*

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Via Healthcare IT News:

The Certification Commission for Health Information Technology has certified 14 electronic health record products that pass muster for provider use under the American Recovery and Reinvestment Act of 2009 (ARRA).

"We believe it will be a challenge for providers who have not yet begun to evaluate products to purchase and implement EHR technology and achieve meaningful use in time for the 2011-2012 incentives," said Alisa Ray, the CCHIT's executive director. "We have received more than 30 applications for our 2011 certification programs – more than half of which are for the comprehensive program – and are announcing new certifications regularly so providers can begin to consider EHR technology that demonstrates compliance with the proposed federal standards."

According to Ray, the Preliminary ARRA 2011 program is a modular, limited certification and inspects technology only against the federal standards. It offers flexibility for health IT companies, developers and providers in meeting ARRA 2011-2012 certification requirements.

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While the ONCHIT Advisory Committees continue to work on defining "meaningful use," the Certification Commission for Health Information Technology (CCHIT) plans to launch a new certification program for electronic health records systems based on the new requirements for such systems to qualify for incentive payments under the American Recovery and Reinvestment Act of 2009 (ARRA).  

On October 7, 2009, CCHIT will "offer a modular certification program called Preliminary ARRA 2011 that is limited to the standards for qualifying EHR technology under the American Recovery and Reinvestment Act (ARRA)."

More from the CCHIT press release:

The Commission has followed and analyzed the emerging recommendations of the health information technology advisory committees to the Office of the National Coordinator (ONC), and believes there is sufficient information to offer the preliminary ARRA certification now.

HHS criteria and standards are expected to be published by the end of 2009. Final rules on Meaningful Use are expected later in the Spring of 2010. If that process results in the introduction of new requirements, the Commission will offer vendors with preliminary certifications an incremental inspection at no additional fee to bring their certifications into alignment with the final rules. The Commission’s certification materials including criteria, test scripts and certification policies for both programs will be published at http://cchit.org on September 24. Applications for certification will open online on October 7.

"Certification Commission Launching 2011 Certification Programs In October," CCHIT press release (September 8, 2009).

"Federal committees to continue work on meaningful use," Healthcare IT News (September 11, 2009).

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Via Government Health IT:

The federal Health IT Policy Committee today endorsed recommendations that would leave the Certification Commission for Health IT in the short term as the sole organization authorized to certify health IT systems that qualified for funding under the economic stimulus plan. More certifying organizations would be added later.

Certification of electronic health record systems that met federal criteria for “meaningful use” of health IT could start as early as October, members of the Department of Health and Human Services’ Health IT Policy Committee said at the August 14th meeting.

Under the plan, CCHIT would provide a preliminary stamp of approval that health IT systems were HHS-qualified or certified until a final meaningful use regulation is published at the end of the year, said Marc Probst, chief information office of Intermountain Healthcare and co-chairman of the Committee’s certification work group.

Preliminary certification is meant to give providers and vendors enough certainty to proceed with planning, designing and purchasing systems in 2010. The HHS certification-qualification would mean that a provider purchasing the systems would be eligible for Medicare and Medicaid incentive payments under the stimulus law beginning in 2011.

"CCHIT will be sole health IT certifier, for now," Government Health IT (August 14, 2009).

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