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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

Medical Scribes Move Outside the ER to Help Clinicians in Other Healthcare Settings Make the Switch From Paper Charts to EHRs

Scribe-assisted physicians say their productivity is back to normal after plummeting with connection to an EHR and have time to spare

One unintended consequence of the federal program to encourage hospitals and physicians to adopt and use electronic health record (EHRS) systems is the creation of a new category of healthcare worker. Today, a growing number of hospitals and medical groups are hiring medical scribes.

Medical scribes are trained individuals who document physician-patient encounters in real-time while a physician is examining the patient. Dark Daily was one of the first to call attention to this new healthcare profession. Medical scribes got their start several years ago working in emergency rooms (ER) to help increase ER physician productivity [See Dark Daily: Adoption of EMRs Creates Demand for New Healthcare Job of ‘Scribes’].

Now, thanks in part to $15.5 billion in federal funding under the American Recovery and Reinvestment Act of 2009, medical scribes are assisting physicians outside the ER. They can be found with doctors making hospital rounds and in medical practices, entering patient medical data into EHRs while physicians are examining or interacting with patients, noted a report published in Modern Healthcare. (more…)

GOP Senators Join House Republicans in Calling for an End to EHR Payments

Unexpected opposition to EHR incentive program should be watched by pathologists and clinical laboratory managers

Questions about the value of the federal government’s program to encourage provider adoption of electronic health record (EHR) systems were raised by Republican leaders in both houses of Congress just weeks before the election on November 6.

Because clinical laboratories and pathology groups have a big stake in interfacing their laboratory information systems to physicians’ EHRs, this new development bears watching.

In October, GOP Senators and House Republicans joined together and issued a call for an immediate halt to distribution of incentive payments to providers for implementing electronic health record (EHR) systems. This program is now in its second full year of implementation. (more…)

More Physician Use of EHRs Could Increase Medical Malpractice Claims

Because they provide medical lab test results to EHRs, clinical labs and pathologists are often named in medical malpractice lawsuits

Some experts predict that the great expansion in the number of physicians using electronic health record (EHR) systems may trigger an increase in medical malpractice lawsuits. Were this were to happen, clinical laboratories and pathology group practices might find themselves also named in such lawsuits because they provided the medical laboratory test results that populated the patient’s EHR.

Concern about an increase in medical malpractice claims surfaced in response to the speed at which the federal government is pushing physicians to implement and use electronic health record (EHR) systems as required under the 2009 American Recovery and Reinvestment Act (ARRA). For example, federal officials are directing hospitals to implement EHRs that fulfill the Act’s Meaningful Use (MU) requirements by 2012. (more…)

Ranking Top 10 Hospital EMR Vendors by Number of Installed Systems

Clinical pathology laboratories will keep busy interfacing their LISs to these EMRs

Tis the season of electronic health records (EHR), now that both hospitals and physicians can qualify to earn incentives from the federal government when they implement these solutions and meet “meaningful use” criteria.

It is possible for individual hospitals to receive incentives totaling as much as $2 million for implementing a certified EHR. This is powerful motivation for cash-strapped hospitals. For that reason, pathologists and clinical laboratory managers of hospital laboratories can expect to be busy ensuring that their laboratory information system (LIS) interfaces properly with the EMR of their parent hospital.

(more…)

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