Ever since the invention of the internet, medical advances based on internet platforms have resulted in significant patient benefits, such as data mining for cures and enhanced physician communications with experts. Another major development was the establishment of the Electronic Health Record (EHR), which has enhanced the healthcare industry by minimizing human error, preventing medical inaccuracies, reducing overall expenses and so much more.
An Electronic Health Record (EHR) is an automated system of storing, maintaining and updating patients’ medical records diminishing common mistakes associated with paper charts with indecipherable handwriting in a physical filing structure. Missing documents and duplicated files could suddenly be a thing of the past. EHR allows convenience and the safe sharing of information with patients and medical practitioners and is also a great source of clinical data. The EHR can easily sound like a streamlining dream, and is, but with new systems come new responsibilities to govern them.
Recently, a leading electronic records vendor, eClinicalWorks (ECW) of Massachusetts, agreed to settle a lawsuit in excess of $155 million based on certification issues and allegations of illicitly paying customers for public promotion. The lawsuit was filed under the qui tam provisions of the False Claims Act by a whistleblower who was a software technician in the Healthcare Division and who will receive an award of approximately $30 million as a result.
According to the Department of Justice (DOJ), eClinicalWorks falsely acquired certification, misrepresented software capabilities and did not meet regulatory requirements. In its complaint-in-intervention, the government contends that ECW falsely obtained that certification for its EHR software when it concealed from its certifying entity that its software did not comply with the requirements for certification. For example, in order to pass certification testing without meeting the certification criteria for standardized drug codes, the company modified its software by “hardcoding” only the drug codes required for testing. In other words, rather than programming the capability to retrieve any drug code from a complete database, ECW simply typed the 16 codes necessary for certification testing directly into its software. ECW’s software also did not accurately record user actions in an audit log and in certain situations did not reliably record diagnostic imaging orders or perform drug interaction checks. In addition, ECW’s software failed to satisfy data portability requirements intended to permit healthcare providers to transfer patient data from ECW’s software to the software of other vendors. As a result of these and other deficiencies in its software, ECW caused the submission of false claims for federal incentive payments based on the use of ECW’s software.These charges tie into the Electronic Health Records (EHR) Incentive Program, which was created to improve service to patients by prompting healthcare providers to obtain certified EHR technology and to ensure that the technology satisfies necessary requirements of use. For companies to attain certification, they must prove the EHR software meets the standards set out by the U.S. Department of Health and Human Services (HHS) in addition to going through a testing process by an HHS-approved body.
The government alleges that ECW deliberately did not disclose deficiencies when the software was being checked. For instance, the DOJ states that “…to pass testing without meeting the criteria for standardized drug codes, the company modified its software by ‘hardcoding’ drug codes”. This means that during the examination phase, ECW did not program the system to completely function as mandated but instead, manually entered material that would allow them to successfully pass the test.
Of course, healthcare fraud is not a revolutionary concept. A substantial portion of money recovered by the federal government over the last thirty years has originated from healthcare-related cases. However, what might be revolutionary is the circumstances that gave rise to this false claim and the rippling effect it may have within the digital sphere. How many other companies, laboratories and medical facilities are utilizing software that has bypassed certification requirements?
ECW’s website asserts that over “125,000 doctors and nurses, and 850,000 medical professionals use their solutions”. With such an extensive reach, it is imperative that the appropriate arms of government properly investigate, monitor and resolve matters involving fraud and other unlawful activities. Therefore, this victorious settlement might very well represent more than dollars and cents.
If you are interested in blowing the whistle on fraud, contact Whistleblower Help Center®.