News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Final Stage 2 rules give providers another year to meet Stage 1 ‘meaningful use’ criteria and shorten Stage 2 requirements from one-year to just 90 days

Clinical laboratory managers and pathologists may be interested to know that, over the fall months, the U.S. Department of Health and Human Services (HHS) released three new rules that affect users of health information technology (HIT).

One rule covers Stage Two of Meaningful Use and includes guidance on how providers should address the need to encrypt patient data. The second rule updates eligibility criteria that providers implementing electronic health record (EHR) systems must meet to qualify for federal incentives. Because medical laboratories and pathology groups maintain ongoing electronic interfaces with hospitals and office-based physicians, it is useful to know some of the key elements of these three recently issued federal regulations. The third rule establishes a date for conversion to ICD-10.

The new regulations were contained in a 1,354-page document published in the Federal Register. These rules represent “a tsunami of change” for providers, observed Patricia B. Wise, RN, MS, MA, COL (USA ret’d), Vice President for healthcare information systems for the Chicago-based Healthcare Information Exchange and Management Systems Society (HIMSS). Wise was quoted in a Modern Healthcare story.

Rule 1: Stage 2 Meaningful Use Criteria Finalized

The most welcome and noncontroversial of these regulations, said Wise, is final Stage 2 “Meaningful Use” rules for electronic health record users. She noted that the new regulations provide continuity between Stage 1 and Stage 2 architecture.

John Halamka, M.D

John Halamka, M.D., is Vice Chairman of the federally chartered Health IT Standards Committee in addition to his responsibilities as the CIO for Beth Israel Deaconess Medical Center in Boston, Massachusetts. He is supporting the Stage 2 rules of meaningful use that establish defined sets of standards for electronic health record systems. (Photo copyright by Greg Hinson, M.D.,)

The recently-issued rules create a set of core criteria that everyone must meet and a second set of “menu” criteria from which providers can choose their targets. “Most of what were menu items in Stage 1 have become core criteria in Stage 2,” explained Wise. “That gives the industry a roadmap as to what’s coming.”

While Stage 1 Meaningful Use had focused heavily on the capture and sharing of data, an article in pointed out that Stage 2 requirements focus more on advanced clinical processes. Therefore, changes to core objectives include increased patient engagement and more care-coordination activities.

Significant changes in meaningful use criteria, include:

  • A one-year extension for early participants in the EHR-incentive program meaningful use criteria;
  • A reduction in the length of time providers need to meet the 2014 Stage 2 requirements, from the proposed one year to just 90 days; and,
  • A new rule for submitting “attestation,” or verification of eligibility of physicians. The change now allows medical groups to submit information for all medical professionals in a group at once and is expected to be a major timesaver for large medical groups.

CMS Rule Calls for Use of Encryption to Secure Patient Records

Healthcare professionals, including clinical laboratory managers, with responsibility for the security of patient records should pay particular attention to another element of the Stage 2 rule. It contains “subtle but forceful” encouragement for hospitals, physicians and other professionals to take a new look at data encryption. The Modern Healthcare report noted that this rule was written by the Centers for Medicare and Medicaid Services (CMS) following a HHS analysis that found that 40% of large breaches in patient records involved lost or stolen devices. “Had these devices been encrypted, their data would have been secured,” noted the authors of the CMS report.

Lisa Gallagher is the HIMSS Senior Director of Privacy and Security. She explained that organizations required by the Health Insurance Portability and Accountability Act (HIPAA) to perform security risk assessments should now consider encryption as part of mitigating controls for risk assessments.

Rule 2: New ONC Requirements for Eligibility in EHR Incentive Program

Another new HIT rule, which came out of the Office of the National Coordinator (ONC), provides 2014 EHR standards and certification criteria. This rule establishes new eligibility requirements for the federal EHR-incentive program.

To be eligible for payments under Stage 2 rules, EHRs must use defined sets of standards for message content, for transport, and for clinical vocabularies, so “everyone is speaking the same language with common code sets,” explained John Halamka, M.D.. Halamka serves as Chief Information Officer for Beth Israel Deaconess Medical Center in Boston and is Vice Chairman of the federally chartered Health IT Standards Committee, which advises the ONC.

Hospitals must use software certified to the 2014 criteria by October 1, 2013. Physicians and other healthcare professionals have until January 1, 2014, to upgrade their EHRs to the new standards.

In addition, hospital-based eligible providers (EP), including in-house pathologists and medical laboratories, may qualify to receive incentive payments, noted the report. These providers can apply for incentive payments as a “Non-Hospital-based EP” if they fund acquisition, implementation, maintenance, hardware and interfaces of certified EHR technology needed to meet Meaningful Use and are not reimbursed by the hospital.

Rule 3: Adoption of ICD-10 Set for October 1, 2014

Lastly, a new rule from HHS delays the start date for the national conversion to ICD-10 codes to October 1, 2014, noted Modern Healthcare reporter Joseph Conn. He pointed out that the American Medical Association (AMA) is still “wary of the planned ICD-10 compliance date and previously asked the CMS to push the compliance date to 2015 or skip ICD-10 altogether and adopt ICD-11, which is under development and could be released by 2015.

Designed to facilitate the transition to a digital environment, ICD-10 adopts updated versions of diagnostic and procedural code sets used in electronic healthcare transactions.  The ICD-10 code sets will replace the current ICD-9-CM code set and must be used on all HIPAA transactions.

Taken together, these three federal rules will require an appropriate response by clinical laboratories and pathology groups to stay compliant. Of equal importance, labs will need to be nimble in supporting their parent hospitals and their office-based physician clients as they take their own steps to implement and comply with these new federal requirements.

—By Patricia Kirk

Related Information:

Health Information Technology: Revisions to the 2014 Edition Electronic Health Record Certification Criteria; and Medicare and Medicaid Programs; Revisions to the Electronic Health Record Incentive Program

Meaningful Use Stage 2 Final Rules

Secretary Sebelius spotlights new efforts to empower patients to increase secure access to their health information

Stage 2 Meaningful Use – Public Health

HHS Proposes One-Year Delay for ICD-10 Implementation: Is This Good News for Clinical Pathology Laboratories?

Executive War College 2013 Topic:

Meaningful Use Stage 2: Winning Ways Your Lab Can Succeed with Physicians, Reduce Your EHR Interface Backlog, and Grow Your Business