Three EHR Vendors Meet Meaningful Use 2014 Standard, Creates Challenge for EPs Wishing to Achieve Stage 2

HITECH Act Meaningful Use Final Rule

On September 4, 2012, CMS published the HITECH Act final rule listing Stage 2 criteria for the ARRA HITECH Act of 2009, Meaningful Use of Electronic Health Records, that eligible professionals (EPs), hospitals, and critical access hospitals (CAHs) have to meet to continue to participation in Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs.

By June 13, 2013, only three vendors were ready for inpatient, and three for ambulatory on the CMS website that shows which EHR vendors have their product certified for Meaningful Use under the 2014 Standard.

This creates an issue for all Eligible Providers (EPs) who achieved meaningful use Stage 1.  Unless their EHR vendor meets the Stage 2 requirements, those EPs no longer qualify for Meaningful Use stimulus dollars.  Subseqently the ONC Certified Electronic Health Record Technology (CEHRT) vendors increased certification levels enabled more EPs and EHs to attest.

Today the ONCHPL web site provides information on certified vendor software in compliance with the HITECH Act.

These developments come in the same year that all HIPAA Covered Entities should be moving toward ICD-10.

The 2014 Edition Standards and Certification Criteria final rule for Meaningful Use

As provided or in 45 CFR Part 170 RIN 0991–AB82 – Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology, the new Rule:

  • Introduces new privacy, security, interoperability, safety, portability, quality measures, and transitions of care standards.
  • Redefines the meaning of Certified EHR Technology (CEHRT) while aiming to permit greater innovation and reduced regulatory burden;
  • Adopts certification criteria for transitions of care that will ensure EHR technology supports standards-based electronic health information exchange
  • Requires test reports used for EHR technology certification be made publicly available and that EHR technology developers follow certain price transparency practices related to the types of costs (i.e., one-time, ongoing, or both) associated with EHR technology implementation for meaningful use; and
  • Makes available for the first time, “gap certification” for certain certification criteria, which will enable more efficient EHR technology certification.

Details of many provisions from the 2014 Edition Meaningful Use / HITECH Act Final Rule below:

III. Provisions of the Final Rule Affecting Standards, Implementation Specifications, and Certification Criteria

A. 2014 Edition EHR Certification Criteria

1. Certification Criteria Relationship to MU
2. Applicability
3. Scope of a Certification Criterion for Certification
4. Explanation and Revision of Terms Used in Certification Criteria
5. Consensus-Based Standards
6. Adopting Versions of Standards
7. Display of Vocabulary Standards
8. Common Data Elements in CertificationCriteria
9. New Certification Criteria
a. Ambulatory and Inpatient Setting
b. Ambulatory Setting
c. Inpatient Setting
10. Revised Certification Criteria
a. Ambulatory and Inpatient Setting
b. Ambulatory Setting
c. Inpatient Setting
11. Unchanged Certification Criteria
a. Refinements to Unchanged Certification Criteria
b. Unchanged Certification Criteria Without Refinements
12. Gap Certification
13. ‘‘Disability’’ Status

B. Redefining Certified EHR Technology and Related Terms

1. Certified EHR Technology (CEHRT) Definition
2. Base EHR Definition
3. Complete EHR Definition
4. Certifications Issued for Complete EHRs and EHR Modules
5. Adaptations of Certified Complete EHRs or Certified EHR Modules

IV. Provisions of the Final Rule Affecting the
Permanent Certification Program for HIT (‘‘ONC HIT Certification Program’’)

A. Program Name Change
B. ‘‘Minimum Standards’’ Code Sets
C. Revisions to EHR Module Certification Requirements
1. Privacy and Security Certification
2. Certification to Certain New Certification Criteria
D. ONC–ACB Reporting Requirements E. Continuation and Representation ofCertified Status
1. 2011 or 2014 Edition EHR Certification Criteria Compliant
2. Updating a Certification
3. Representation of Meeting the Base EHR definition
F. EHR Technology Price Transparency G. Certification and Certification Criteria for Other Health Care Settings

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Michael F. Arrigo

Michael Arrigo, an expert witness, and healthcare executive, brings four decades of experience in the software, financial services, and healthcare industries. In 2000, Mr. Arrigo founded No World Borders, a healthcare data, regulations, and economics firm with clients in the pharmaceutical, medical device, hospital, surgical center, physician group, diagnostic imaging, genetic testing, health I.T., and health insurance markets. His expertise spans the federal health programs Medicare and Medicaid and private insurance. He advises Medicare Advantage Organizations that provide health insurance under Part C of the Medicare Act. Mr. Arrigo serves as an expert witness regarding medical coding and billing, fraud damages, and electronic health record software for the U.S. Department of Justice. He has valued well over $1 billion in medical billings in personal injury liens, malpractice, and insurance fraud cases. The U.S. Court of Appeals considered Mr. Arrigo's opinion regarding loss amounts, vacating, and remanding sentencing in a fraud case. Mr. Arrigo provides expertise in the Medicare Secondary Payer Act, Medicare LCDs, anti-trust litigation, medical intellectual property and trade secrets, HIPAA privacy, health care electronic claim data Standards, physician compensation, Anti-Kickback Statute, Stark law, the Affordable Care Act, False Claims Act, and the ARRA HITECH Act. Arrigo advises investors on merger and acquisition (M&A) diligence in the healthcare industry on transactions cumulatively valued at over $1 billion. Mr. Arrigo spent over ten years in Silicon Valley software firms in roles from Product Manager to CEO. He was product manager for a leading-edge database technology joint venture that became commercialized as Microsoft SQL Server, Vice President of Marketing for a software company when it grew from under $2 million in revenue to a $50 million acquisition by a company now merged into Cincom Systems, hired by private equity investors to serve as Vice President of Marketing for a secure email software company until its acquisition and multi $million investor exit by a company now merged into Axway Software S.A. (Euronext: AXW.PA), and CEO of one of the first cloud-based billing software companies, licensing its technology to Citrix Systems (NASDAQ: CTXS). Later, before entering the healthcare industry, he joined Fortune 500 company Fidelity National Financial (NYSE: FNF) as a Vice President, overseeing eCommerce solutions for the mortgage banking industry. While serving as a Vice President at Fortune 500 company First American Financial (NYSE: FAF), he oversaw eCommerce and regulatory compliance technology initiatives for the top ten mortgage banks and led the Sarbanes Oxley Act Section 302 internal controls I.T. audit for the company, supporting Section 404 of the Sarbanes Oxley Act. Mr. Arrigo earned his Bachelor of Science in Business Administration from the University of Southern California. Before that, he studied computer science, statistics, and economics at the University of California, Irvine. His post-graduate studies include biomedical ethics at Harvard Medical School, biomedical informatics at Stanford Medical School, blockchain and crypto-economics at the Massachusetts Institute of Technology, and training as a Certified Professional Medical Auditor (CPMA). Mr. Arrigo is qualified to serve as a director due to his experience in healthcare data, regulations, and economics, his leadership roles in software and financial services public companies, and his healthcare M&A diligence and public company regulatory experience. Mr. Arrigo is quoted in The Wall Street Journal, Fortune Magazine, Kaiser Health News, Consumer Affairs, National Public Radio (NPR), NBC News Houston, USA Today / Milwaukee Journal Sentinel, Medical Economics, Capitol ForumThe Daily Beast, the Lund Report, Inside Higher Ed, New England Psychologist, and other press and media outlets. He authored a peer-reviewed article regarding clinical documentation quality to support accurate medical coding, billing, and good patient care, published by Healthcare Financial Management Association (HFMA) and published in Healthcare I.T. News. Mr. Arrigo serves as a member of the board of directors of a publicly traded company in the healthcare and data analytics industry, where his duties include: member, audit committee; chair, compensation committee; member, special committee.

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