[{"innerBlocks":[],"name":"core\/freeform","postId":3144,"blockType":{"name":"core\/freeform","keywords":[],"attributes":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"providesContext":[],"usesContext":[],"selectors":[],"supports":{"className":false,"customClassName":false,"reusable":false},"styles":[],"variations":[],"apiVersion":3,"title":"Classic","description":"Use the classic WordPress editor.","category":"text"},"originalContent":"The Department of Health and Human Services\u2019 Office of Inspector General is sending a strong warning to electronic health record vendors: it will not tolerate representations that their software has certain functionality if their products actually can\u2019t do it.

In May, eClinicalWorks\u2014one of the nation\u2019s largest EHR vendors\u2014and three of its founding executives agreed to pay $155 million as part of a settlement with the Department of Justice that the company allegedly violated the False Claims Act by misrepresenting the capabilities of its software.

According to OIG Senior Counsel John O\u2019Brien, based on the DOJ allegation, eClinicalWorks caused providers using its software\u2014which did not meet Meaningful Use certification requirements\u2014to unknowingly submit false claims to the Medicare and Medicaid EHR Incentive Program.

In settling the case, eClinicalWorks denied any wrongdoing and said it fully cooperated with DOJ\u2019s civil investigation. OIG noted that the case was never adjudicated in a court, but resolved in a False Claims Act resolution to expedite the process.

\u201cWe\u2019re entering an entirely new area of healthcare fraud,\u201d says O\u2019Brien. The action against eClinicalWorks is \u201cthe first-ever civil settlement that we\u2019ve had with an EHR vendor.\u201d

Along with its partners in law enforcement, he adds that OIG will vigilantly investigate any such alleged misconduct that potentially puts patient safety at risk and results in financial losses to the federal government.

\u201cWe take the certification process for EHR software very seriously\u2014there\u2019s no room for manipulating this process and making false statements during the certification process,\u201d warns O\u2019Brien. \u201cWhen there are allegations of manipulation of the certification process, OIG takes those allegation very seriously.\u201d

O\u2019Brien will not comment on whether OIG has any open investigations of other EHR vendors. However, he says that the agency does accept these kinds of complaints from providers via OIG\u2019s website and hotline for reporting fraud.

Asked whether eClinicalWorks was an anomaly, O\u2019Brien concludes that with \u201call conduct that comes to our attention there\u2019s usually not just one actor,\u201d adding that OIG\u2019s \u201cground-breaking\u201d corporate integrity agreement in this particular case \u201cwill likely be used in future cases.\u201d

Also See<\/b>: Why the eClinicalWorks settlement may rattle the industry<\/a>

DOJ contends that eClinicalWorks falsely obtained certification for its EHR software when it concealed from its certifying entity that its software did not comply with the requirements for certification. Specifically, in order to pass certification testing without meeting the certification criteria for standardized drug codes, the vendor allegedly modified its software by \u201chardcoding\u201d only the drug codes required for testing.

However, eClinicalWorks denied any wrongdoing in its formal statement on the settlement, adding that it fully cooperated with DOJ\u2019s civil investigation. \u201cThe claims settled by the agreement are allegations only, and there has been no determination of liability,\u201d according to the company statement. \u201cAlthough eCW disputed the DOJ\u2019s allegations, it decided to settle to avoid the cost and uncertainty inherent in protracted litigation.\u201d

O\u2019Brien emphasizes that \u201cwhat was resolved here are allegations\u2014the facts were not adjudicated in a court.\u201d At the same, however, he adds that the allegations \u201cinvolved alleged conduct that OIG and DOJ determined was of a nature that needed to be addressed by a False Claims Act resolution with a corporate integrity agreement.\u201d

A five-year corporate integrity agreement<\/a>, signed by eClinicalWorks as part of the settlement and crafted in part by O\u2019Brien, requires the company to take several corrective steps to continue to participate in federal healthcare programs. \u201cIt has specific requirements related to the quality of EHR software,\u201d he observes.

Under the extensive agreement, eClinicalWorks must retain an independent software quality oversight organization approved by OIG to assess its software quality control systems and provide written semi-annual reports to the agency documenting its reviews and recommendations.

\u201cEvery six months, this oversight organization will be responsible for assessing eClinicalWorks\u2019 quality control systems for its EHR software,\u201d says O\u2019Brien.

In addition, the company must notify and provide its customers the opportunity\u2014free of charge\u2014 to obtain the latest versions of their software, according to O\u2019Brien, as well as give customers the option of having eClinicalWorks transfer their data to another EHR vendor without penalties or service charges.

The corporate integrity agreement also prohibits eClinicalWorks from restricting its customers from discussing\u2014in any forum\u2014problems that they might be experiencing with the vendor\u2019s software, he points out.

\u201cThese are unique provisions that I think will reduce any patient safety risks associated with the use of eClinicalWorks\u2019 software, because customers will have easier access to the most updated software\u2014or be able to switch easily to other EHR vendors\u2014and will not be prevented from openly communicating with each other about any problems,\u201d contends O\u2019Brien.

However, so far, eClinicalWorks appears to have weathered the settlement unscathed. The company on July 28 reported its strongest sales month of 2017, with more than 1,000 providers selecting its EHR solution in June, while second quarter of 2017 showed excellent results resulting in more than 3,000 providers being added to its customer base and revenues of $120 million. Also, in the first six months of 2017, 70 percent of eClinicalWorks\u2019 new providers switched from different EHRs, according to the vendor.

Nonetheless, providers are well aware of the company\u2019s settlement with the government, which has increased concerns in the marketplace. A new survey<\/a> of healthcare professionals conducted by Reaction Data\u2019s Research Cloud shows that 27 percent of respondents indicated they have decreased confidence in their EHR vendor as a result of the eClinicalWorks settlement, while 35 percent are now significantly more suspicious of other EHR vendors.

\u201cA big takeaway from this research is the unfortunate increase in the level of distrust that providers generally feel toward all EHR suppliers (including their own suppliers in many cases), because of the actions of a few,\u201d states the report.","saveContent":"The Department of Health and Human Services\u2019 Office of Inspector General is sending a strong warning to electronic health record vendors: it will not tolerate representations that their software has certain functionality if their products actually can\u2019t do it.

In May, eClinicalWorks\u2014one of the nation\u2019s largest EHR vendors\u2014and three of its founding executives agreed to pay $155 million as part of a settlement with the Department of Justice that the company allegedly violated the False Claims Act by misrepresenting the capabilities of its software.

According to OIG Senior Counsel John O\u2019Brien, based on the DOJ allegation, eClinicalWorks caused providers using its software\u2014which did not meet Meaningful Use certification requirements\u2014to unknowingly submit false claims to the Medicare and Medicaid EHR Incentive Program.

In settling the case, eClinicalWorks denied any wrongdoing and said it fully cooperated with DOJ\u2019s civil investigation. OIG noted that the case was never adjudicated in a court, but resolved in a False Claims Act resolution to expedite the process.

\u201cWe\u2019re entering an entirely new area of healthcare fraud,\u201d says O\u2019Brien. The action against eClinicalWorks is \u201cthe first-ever civil settlement that we\u2019ve had with an EHR vendor.\u201d

Along with its partners in law enforcement, he adds that OIG will vigilantly investigate any such alleged misconduct that potentially puts patient safety at risk and results in financial losses to the federal government.

\u201cWe take the certification process for EHR software very seriously\u2014there\u2019s no room for manipulating this process and making false statements during the certification process,\u201d warns O\u2019Brien. \u201cWhen there are allegations of manipulation of the certification process, OIG takes those allegation very seriously.\u201d

O\u2019Brien will not comment on whether OIG has any open investigations of other EHR vendors. However, he says that the agency does accept these kinds of complaints from providers via OIG\u2019s website and hotline for reporting fraud.

Asked whether eClinicalWorks was an anomaly, O\u2019Brien concludes that with \u201call conduct that comes to our attention there\u2019s usually not just one actor,\u201d adding that OIG\u2019s \u201cground-breaking\u201d corporate integrity agreement in this particular case \u201cwill likely be used in future cases.\u201d

Also See<\/b>: Why the eClinicalWorks settlement may rattle the industry<\/a>

DOJ contends that eClinicalWorks falsely obtained certification for its EHR software when it concealed from its certifying entity that its software did not comply with the requirements for certification. Specifically, in order to pass certification testing without meeting the certification criteria for standardized drug codes, the vendor allegedly modified its software by \u201chardcoding\u201d only the drug codes required for testing.

However, eClinicalWorks denied any wrongdoing in its formal statement on the settlement, adding that it fully cooperated with DOJ\u2019s civil investigation. \u201cThe claims settled by the agreement are allegations only, and there has been no determination of liability,\u201d according to the company statement. \u201cAlthough eCW disputed the DOJ\u2019s allegations, it decided to settle to avoid the cost and uncertainty inherent in protracted litigation.\u201d

O\u2019Brien emphasizes that \u201cwhat was resolved here are allegations\u2014the facts were not adjudicated in a court.\u201d At the same, however, he adds that the allegations \u201cinvolved alleged conduct that OIG and DOJ determined was of a nature that needed to be addressed by a False Claims Act resolution with a corporate integrity agreement.\u201d

A five-year corporate integrity agreement<\/a>, signed by eClinicalWorks as part of the settlement and crafted in part by O\u2019Brien, requires the company to take several corrective steps to continue to participate in federal healthcare programs. \u201cIt has specific requirements related to the quality of EHR software,\u201d he observes.

Under the extensive agreement, eClinicalWorks must retain an independent software quality oversight organization approved by OIG to assess its software quality control systems and provide written semi-annual reports to the agency documenting its reviews and recommendations.

\u201cEvery six months, this oversight organization will be responsible for assessing eClinicalWorks\u2019 quality control systems for its EHR software,\u201d says O\u2019Brien.

In addition, the company must notify and provide its customers the opportunity\u2014free of charge\u2014 to obtain the latest versions of their software, according to O\u2019Brien, as well as give customers the option of having eClinicalWorks transfer their data to another EHR vendor without penalties or service charges.

The corporate integrity agreement also prohibits eClinicalWorks from restricting its customers from discussing\u2014in any forum\u2014problems that they might be experiencing with the vendor\u2019s software, he points out.

\u201cThese are unique provisions that I think will reduce any patient safety risks associated with the use of eClinicalWorks\u2019 software, because customers will have easier access to the most updated software\u2014or be able to switch easily to other EHR vendors\u2014and will not be prevented from openly communicating with each other about any problems,\u201d contends O\u2019Brien.

However, so far, eClinicalWorks appears to have weathered the settlement unscathed. The company on July 28 reported its strongest sales month of 2017, with more than 1,000 providers selecting its EHR solution in June, while second quarter of 2017 showed excellent results resulting in more than 3,000 providers being added to its customer base and revenues of $120 million. Also, in the first six months of 2017, 70 percent of eClinicalWorks\u2019 new providers switched from different EHRs, according to the vendor.

Nonetheless, providers are well aware of the company\u2019s settlement with the government, which has increased concerns in the marketplace. A new survey<\/a> of healthcare professionals conducted by Reaction Data\u2019s Research Cloud shows that 27 percent of respondents indicated they have decreased confidence in their EHR vendor as a result of the eClinicalWorks settlement, while 35 percent are now significantly more suspicious of other EHR vendors.

\u201cA big takeaway from this research is the unfortunate increase in the level of distrust that providers generally feel toward all EHR suppliers (including their own suppliers in many cases), because of the actions of a few,\u201d states the report.","order":0,"get_parent":{},"attributes":[],"attributesType":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"dynamicContent":""}]

OIG puts EHR vendors on notice in wake of eClinicalWorks settlement

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