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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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DOJ Pursues Organizations That Falsely Claim Compliance with Medicare’s EHR Incentive Programs

Clinical laboratories that interface with hospital EHR systems under scrutiny by the DOJ could be drawn into the investigations

Officials at the federal US Department of Justice (DOJ) continue to pursue fraud cases involving health systems that allegedly have falsely attested to complying with the Medicare and Medicaid electronic health record (EHR) adoption incentive programs (now known as the Promoting Interoperability Programs).

This is important for clinical laboratory leaders to watch, because medical labs often interface with hospital EHRs to exchange vital patient data, a key component of complying with Medicare’s EHR incentive programs. If claims of interoperability are shown to be false, could labs engaged with those hospital systems under scrutiny be drawn into the DOJ’s investigations?

Violating the False Claims Act

In May, Coffey Health System (CHS), which includes Coffey County Hospital, a 25-bed critical access hospital located in Burlington, Kan., agreed to pay the US government a total of $250,000 to settle a claim that it violated the False Claims Act.

CHS’ former CIO filed the qui tam (aka, whistleblower) lawsuit, which allows individuals to sue on behalf of the government and share in monetary recovery. He alleged that CHS provided false information to the government about being in compliance with security standards to receive incentive payments under the EHR Incentive Program.

According to a DOJ press release, “the United States alleged that Coffey Health System falsely attested that it conducted and/or reviewed security risk analyses in accordance with requirements under a federal incentive program for the reporting periods of 2012 and 2013. The government contended that the hospital submitted false claims to the Medicare and Medicaid Programs pursuant the Electronic Health Records (EHR) Incentive Program.”

“Medicare and Medicaid beneficiaries expect that providers ensure the accuracy and security of their electronic health records,” said Stephen McAllister (above), United States Attorney for the District of Kansas, in the DOJ press release. “This office remains committed to protecting the federal health programs and to hold accountable those whose conduct results in improper payments.” (Photo copyright: US Department of Justice.)

How Providers Receive EHR Incentive Program Funds

The original EHR Adoption Incentive Program was part of the Health Information Technology for Economic and Clinical Health (HITECH) Act. The federal government enacted the program as part of the American Recovery and Reinvestment Act of 2009 (the Recovery Act), which was an amendment to the Health Insurance Portability and Accountability Act (HIPAA). 

The Recovery Act allocated $25 billion to incentivize healthcare professionals and facilities to adopt and demonstrate meaningful use (MU) of electronic health records by January 1, 2014. The federal Centers for Medicare and Medicaid Services (CMS) released the incentive funds when providers attested to accomplishing specific goals set by the program.

The website of the Office of the National Coordinator for Health Information Technology (ONC), HealthIt.gov, defines “meaningful use” as the use of digital medical and health records to:

  • Improve quality, safety, efficiency, and reduce health disparities;
  • Engage patients and their families;
  • Improve care coordination and population and public health; and
  • Maintain privacy and security of patient health information.

The purpose of the HITECH Act was to address privacy and security concerns linked to electronic storage and transference of protected health information (PHI). HITECH encourages healthcare organizations to update their health records and record systems, and it offers financial incentives to institutions that are in compliance with the requirements of the program.

When eligible professionals or eligible hospitals attest to being in compliance with Medicare’s EHR incentive program requirements, they can file claims for federal funds, which are paid and audited by the Department of Health and Human Services (HHS) through Medicare and Medicaid.

Institutions receiving funds must demonstrate meaningful use of EHR records or risk potential penalties, including the delay or cancellation of future payments and full reimbursement of payments already received. In addition, false statements submitted in filed documents are subject to criminal laws and civil penalties at both the state and federal levels.

EHR Developers Under Scrutiny by DOJ

EHR vendors also have been investigated and ordered to make restitutions by the DOJ. 

In February, Greenway Health, a Tampa-based EHR developer, agree to pay $57.25 million to resolve allegations related to the False Claims Act. In this case, the government contended that Greenway obtained certification for its “Prime Suite” EHR even though the technology did not meet the requirements for meaningful use.

And EHR vendor eClinicalWorks paid the government $155 million to settle allegations under the False Claims Act. The government maintained that eClinicalWorks misrepresented the capabilities of their software and provided $392,000 in kickbacks to customers who promoted its product. 

Legal cases such as these demonstrate that the DOJ will pursue both vendors and healthcare organizations that misrepresent their products or falsely attest to interoperability under the terms laid out by Medicare’s EHR Incentive Program.

Clinical laboratory leaders and pathology groups should carefully study these cases. This knowledge may be helpful when they are asked to create and maintain interfaces to exchange patient data with client EHRs.

—JP Schlingman

Related Information:

DOJ Pursues More Electronic Health Records Cases

Electronic Health Records Vendor to Pay $57.25 Million to Settle False Claims Act Allegations  

Electronic Health Records Vendor to Pay $155 Million to Settle False Claims Act Allegations

Kansas Hospital Agrees to Pay $250,000 to Settle False Claims Act Allegations

EHR Sales Reached $31.5 Billion in 2018 Despite Concerns over Usability, Interoperability, and Ties to Medical Errors

UCLA Health Pilot Program Looks to Integrate Genomic Patient Data into Epic EHRs: Currently Clinical Pathology Laboratories Store This Data

Use of genomic data collector could mean competition for medical laboratories that now store, analyze, and interpret genetic data

UCLA Health is working to integrate genomic patient data into its Epic electronic health record (EHR) system. This pilot project could signal potential competition for pathology groups and clinical laboratories that currently are the main repositories for the storage, analysis, and interpretation of genetic data.

Pilot Program Designed to Support Precision Medicine Research

As it becomes faster, cheaper, and easier to sequence human exomes and genomes, the challenge is how to store a patient’s gene data and make it available at the time care is provided.

UCLA Health is teaming with Seattle-based startup ActX in an effort to solve this problem. ActX represents a relatively new type of company—a genomic data collector (GDC)—and it is developing a critical solution—EHR Integration. The emergence of GDCs could affect clinical laboratories that currently provide most of the storage, analysis, and interpretation of genetic data.

ActX Founder and CEO Andrew Ury, MD, told MedCity News that, “While genetics can’t predict everything, genetics can predict more and more and whether a patient has a side effect. We think this is the future.”

ActX currently provides genomic decision support to physicians using Allscripts and Greenway Health ambulatory EHRs. A patient’s genetic information is collected through a saliva sample and then analyzed in real-time. Using a patient’s genetic code, the ActX application alerts physicians to possible medication adverse reactions and efficacy as well as actionable medical risks and patients’ carrier status. (more…)

Top 10 Rankings of EHR Market Share Put Epic First as Hospitals, Physicians, and Clinical Laboratories Make Progress on Interoperability

In both the hospital market and the ambulatory market, Epic has the best-selling electronic health records system, according to data issued by ONCHIT

Across the nation, clinical laboratories and pathology groups are busy interfacing their laboratory information (LIS) systems to the electronic health record (EHR) systems of their client hospitals and physicians. Yet, few lab managers know which EHR systems are dominating the market and which EHR systems are barely surviving.

In fact, it can be a challenge to understand market share by vendor. That is because market share can be determined in multiple ways. Dark Daily found three different rankings of EHR vendors. Each was based on slightly different sets of data. (more…)

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