CMS and ONC released proposed and interim regulations on meaningful use and EHR certification late yesterday as the year wound down.

The Centers for Medicare and Medicaid Services released a 556-page notice of proposed rulemaking defining the “meaningful use” of EHRs and describing the provisions governing the incentive programs. [January 13 update: official publication occurred in the Federal Register today.]

The program details, discussed and anticipated through much of the year, enable vendors and providers to begin working toward eligibility for EHR adoption and use incentives described in the American Recovery and Reinvestment Act. Payments to eligible providers begin in late 2010.

The Office of the National Coordinator for Health IT released an interim final rule describing related requirements and technical specifications for EHR technology. Providers must use certified EHRs to participate in the incentive program. The releases were announced in a joint CMS-ONC press conference late yesterday due to their close connection. [January 13 update: official publication occurred in the Federal Register today.]

ONC’s interim final rule will go into effect 30 days from its official publication in the Federal Register. The CMS notice is a proposal, intended to solicit public comment before rulemaking progresses. Publication of both is expected by mid-January. (more…)

Organizations can find further guidance on developing electronic signature policies in the online version of the November–December practice brief “Electronic Signature, Attestation, and Authorship (Updated).”

The online version includes five separate appendixes, linked at the end of the brief:

• Appendix A excerpts portions of the HL7 EHR-System Records Management and Evidentiary Support Functional Profile Standard, which can be used to develop proposals for selecting an EHR system or as a checklist to evaluate current applications for basic record management functionality.
• Appendix B lists the various e-signature laws, regulations, and acts that organizations can refer to in developing and implementing e-signature functionality and policy.
• Appendix C outlines a sample e-signature model policy template, including important legal and compliance recommendations.
• Appendix D provides a glossary of terms that organizations can use in their e-signature policies.
• Appendix E provides practice guidance on making amendments, corrections, and deletions in transcribed reports.

Managing e-signatures is complex, but doing it correctly is critical  in supporting an organization’s legal health record. Successfully implementing and using e-signatures requires proper attention to individual system functionality, regulatory requirements, and organizational policy.

The Department of Health and Human Services announced awards totaling $27.8 million to health center networks and large multi-site health centers to implement health IT.

The funds are part of the $2 billion allotted to HHS’s Health Resources and Services Administration (HRSA) under the American Recovery and Reinvestment Act to expand healthcare services to low-income and uninsured individuals.

The $27.8 million will be used to expand and upgrade health IT systems, including electronic health records, and are related to other ARRA efforts to promote the adoption and use of health IT throughout healthcare.

Eighteen grants totaling more than $22.6 million will support EHR implementations. Grants totaling more than $2.6 million will help four grantees implement other health IT-related projects, including creation of health information exchange networks. Another five grants totaling more than $2.5 million will help health centers use existing EHRs to improve patient health outcomes.

HRSA-supported health centers treated 17 million patients in 2008, 40 percent of whom have no health insurance, according to HHS.

A list of grant recipients is available through the above link. More on ARRA provisions for community health centers is available through the HHS.gov/Recovery site.

Update, September 2: HHS has posted new and revised program materials online: a transcript of its August 27 technical assistance conference, an FAQ, and a revised preliminary application template.

The first applications from aspiring health IT resource centers are due in two weeks—September 8. The Office of the National Coordinator for Health Information Technology will award grants in two additional cycles with initial deadlines in December and June. ONC announced the deadlines in a press event last week.

Program details and the full application schedule appears in the funding opportunity announcement on the Health and Human Services health IT Web site. Applications will be screened in two phases. Successful preliminary applicants will be requested to submit a full application for merit review.

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In the August print issue, Journal writer Chris Dimick describes the challenges California healthcare organizations face in determining their responsibilities under tough new state law on health data breach notification and even newer federal law created by ARRA.

The breach notification requirement is not the only ARRA privacy provision shaking up healthcare organizations in California and across the country. It is just the most pressing—final rules appear this month, and organizations must be compliant within 30 days.

Three additional ARRA provisions around privacy and transparency have providers and vendors buzzing, because current electronic record systems cannot meet the requirements.

In many ways, the three provisions describe what EHR systems should be able to do, not what they can do. In the coming months it is up to the federal government to fill in the details. In the coming months and years, it will be up to providers and vendors to adapt and create systems that meet them.

Dimick’s conversations with privacy experts in California continue below, expanding to new provisions on accounting for disclosure, suppressing disclosure of treatment for services paid out-of-pocket, and providing electronic copies of electronic records.

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Accounting for Disclosure

HIM professionals and others are concerned with ARRA’s new accounting for disclosures provision, which requires healthcare facilities using EHRs to provide an accounting or audit trail of all record disclosures. This represents a major change from the current HIPAA laws, which exempt disclosures for treatment purposes and routine healthcare operations. Most state laws do not address accounting for disclosures, and they rely on HIPAA to set the rules.
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CCHIT, the Certification Commission for Health Information Technology, has been the sole certification source for electronic health record products for some years now, but ARRA may change that. A working group of the Health IT Policy Committee has recommended that multiple organizations conduct certification testing and that the federal government take over the setting of certification criteria.

The ARRA provision that will pay Medicare and Medicaid bonuses to providers who are “meaningful users” of health IT has put heightened focus on certification. Meaningful use has yet to be fully defined, but it will certainly include certified products.

The workgroup presented its recommendations at the policy committee’s July 16 meeting, suggesting that the government widen certification to include more system types than CCHIT currently covers, assume responsibility for establishing certification criteria, and create a process for accrediting multiple organizations to perform certification testing. ARRA established the committee to advise the Office of the National Coordinator for Health IT, part of Health and Human Services, which is responsible for refining and managing the incentive program. (more…)

Healthcare is a step closer to a definition for the “meaningful use” of health IT. The Health IT Policy Committee approved revised recommendations for the “meaningful use” of health IT today, handing them off to the Office of the National Coordinator for Health Information Technology.

The committee’s revision of its earlier recommendations features modified criteria for use of computerized physician order entry and faster adoption of clinical decision support and personal health records among the score of major and minor tweaks.

The committee also offered new recommendations on the rollout of the program’s objectives and measures, which evolve from 2011 to 2015.

ARRA structured the incentives program to encourage providers to get started early. However, with the revisions the committee recommends that the evolving criteria be based on “adoption year” rather than a calendar year. That is, an organization that first seeks to become eligible for the program in 2012 would use the first-year criteria (2011). Otherwise, the committee felt, the “rising tide” of criteria could be a deterrent.

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The American Recovery and Reinvestment Act calls for the creation of regional health IT extension centers that help providers adopt and use health IT such as electronic health records. The Office of the National Coordinator for Health IT published a draft description of the program May 28, requesting comments by June 11.

While ONC’s draft description rightly stressed the delivery of IT assistance, the centers and their clients will require a wider range of expertise for the full preparation, deployment, and management of health information communications and technology. Different phases of EHR implementation and use require differing skills.

In its comments on the draft description, AHIMA recommended that the final program define core services that include a range of services to assist in EHR use throughout a system’s lifecycle.

This range of services includes workflow analysis, transition planning, data analysis, and training. The sample phases of an EHR lifecycle shown below illustrate the differing core services that users may require over the entire lifecycle. (more…)

AHIMA expressed support for a federal program establishing regional health IT extension centers that assist providers, but it registered concern that a program implemented ineffectively would cause confusion and contention and ultimately distract from the goal of EHR adoption and implementation.

AHIMA’s comments were in response to a draft description of the program published May 28 by the Office of the National Coordinator for Health IT. Specified under the American Recovery and Reinvestment Act, the program calls for a central Health IT Research Center with affiliated regional extension centers that provide direct assistance to providers. The centers will help providers meet requirements for receiving bonus Medicare and Medicaid payments under a separate ARRA provision.

AHIMA offered recommendations around four main comments: (more…)

ONC published a draft description of the health IT extension program in today’s Federal Register, requesting comments within two weeks—by June 11.

The extension program is called for under the HITECH Act in ARRA, the American Recovery and Reinvestment Act. It authorizes creation of a National Health Information Technology Research Center and affiliated regional extension centers to assist providers in selecting and implementing certified electronic health records.

The program also will assist providers in becoming “meaningful users” of the systems, a prerequisite to receiving bonus Medicare and Medicaid payments under a separate ARRA provision.

The extension program is to give preference to providers serving uninsured, underinsured, underserved, and special-needs populations. (more…)