The ARPA-H program, called the Platform Accelerating Rural Access to Distributed & InteGrated Medical care, or PARADIGM, is intended to be “a multi-functional, rugged electric vehicle platform” that will employ medical devices capable of conducting screenings and testing for people in rural areas, the agency said in a release. 

That may include things like a mini CT scanner and digital training tools for health care workers, which the program is exploring. According to the release, the program will also seek to build software to connect devices both on the vehicles and remotely with electronic health records systems.

“What we aim to do is to develop a mobile health vehicle unit platform that essentially acts as a unit of a hospital,” Bon Ku, PARADIGM’s program manager, said during a call with reporters Tuesday. “This platform will allow patients not only to have virtual visits, but also to obtain imaging tests, advanced imaging tests, like CT scans, MRIs, ultrasounds, lab testing, and also interventions ranging from maternal health appointments to sophisticated appointments like obtaining dialysis.”

The program will use a program solicitation in five areas, including for a ruggedized CT scanner, a medical Internet of Things platform, and intelligent task guidance, according to the release. The program expects multiple awards and said resources “will depend on the quality of the proposals received and the availability of funds.”

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“In the summer of 2024, we should be having, and even before that we should be having real discussions about whether we’re ready to move forward with [the EHRM] restart,” Dr. Neil Evans, acting program executive director of the VA’s EHRM Office, said during a House Appropriations Oversight hearing on implementation of the VA’s EHRM initiative with Oracle Cerner.

The VA partnered with Oracle Cerner in 2018 to lead the development and implementation of its EHR modernization under a 10-year, $16 billion contract. But since then, the program has faced a number of significant challenges, some of which have reportedly brought harm to veterans. This led to bipartisan congressional criticism of the program and, ultimately, the decision in April by the VA to stop the rollout of the system at veteran hospitals until major patient safety issues are remediated.

The VA also renegotiated its contract with Oracler Cerner in a way that it believes “dramatically increases” its ability to hold the technology company to account for the system’s performance.

Speaking at Wednesday’s hearing, Mike Sicilia, executive vice president at Oracle, said: “I would concur with Dr. Evans’s time frame. It seems to me next summer we should be in a position, particularly if the go-live is trending well in March, that we should be in a position to resume [the rollout]. That is our expectation.” 

VA Secretary Denis McDonough will next year make the final decision regarding the EHR rollout timeframe, according to Evans and Sicilia.

The VA currently uses the Veterans Health Information Systems and Technology Architecture (VistA) EHR system in almost all of its VA hospitals. The modernized EHR system was delivered to five VA facilities before the department halted its nationwide rollout. VistA has faced its own issues including a lack of interoperability and nationwide access for veterans who change hospitals or move between states. 

Evans also said there are major issues in having two different EHR systems operating within the VA rather than one central, functioning EHR system.

“I wake up every day wondering are we moving in this direction? We don’t want to stay in reset forever. In fact, I would argue that we’re at higher risk the longer we maintain a healthcare system that’s running two different electronic healthcare systems. So we need to feel an urgency to move forward with a single electronic health record system,” he said.

Multiple members of Congress expressed strong frustration during the hearing that the VA and Oracle Cerner were not moving fast enough with improvements to the EHR system while spending billions in taxpayer dollars. 

“$10 billion dollars of taxpayer dollars. What the hell has that gotten us? What if we cut funding? What if next year it was zero? Would that light a fire in terms of fixing this program?” said Rep. Tony Gonzales, R-Texas.

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The $31 million dollar agreement follows allegations that the company misrepresented what some versions of its electronic health record (EHR) software was could do and provided “unlawful remuneration” to users as an inducement to recommend the product, the Department of Justice said in a Friday statement.

The DOJ alleged that NextGen “improperly obtained certification for its EHR product” under the 2014 edition of certification program for health technology operated by the Office of the National Coordinator, according to a DOJ complaint filed with the settlement. It then used that certification “to obtain incentive payments.”

NextGen, DOJ alleged, used “an auxiliary product” during the certification that was designed to run test scripts it needed to perform for approval. As a result, the EHR released to users lacked functionalities, such as “the ability to record vital sign data, translate data into required medical vocabularies, and create complete clinical summaries,” the statement said.

The government also alleged that NextGen violated the Anti-Kickback Statute by giving credits to users whose recommendation resulted in a sale of the EHR system. Those credits “often worth as much as $10,000,” DOJ said.

The settlement includes resolution of whistleblower claims brought by two health care professionals — Toby Markowitz and Elizabeth Ringold — under the False Claims Act. The whistleblowers in the case will receive roughly $5.6 million, the DOJ said.

In a written statement regarding the settlement, a NextGen spokesperson said: “The Company denies that any of its conduct violated the law, and the settlement agreement does not include any admissions of wrongdoing. This agreement relates to claims from more than a decade ago.”

The spokesperson added that the settlement doesn’t change NextGen’s products or policies for compliance. They added: “To avoid the distraction and expense of litigation, we believe it is in the best interest of the Company to put this historical matter behind us and keep our attention focused on innovating solutions that enable better healthcare outcomes for all.”

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In a statement on Tuesday, the VA said the renegotiated contract “dramatically increases” the agency’s ability to hold Oracle Cerner accountable across areas including reliability, responsiveness and interoperability.

According to the agency, the new contract will be structured as five one-year terms rather than one five-year term and includes a stipulation that the VA will receive larger monetary credits if Oracle Cerner fails to perform. The original EHR contract with Oracle Cerner had a five-year base period with a five-year option, which is the element that has been renegotiated.

Terms of the updated contract include a requirement that Oracle Cerner comply with 27 other performance metrics in addition to ensuring outage-free time, which is one of the key issues that has dogged the health record system.

Last month, the VA announced it was halting all further implementation of the electronic health record platform while it conducted contracted negotiations with Oracle Cerner over a potential extension of its initial $10 billion IT modernization contract that was signed in 2018 and came to the end of its base performance period.

The contract renegotiation followed pressure from lawmakers like House VA Technology Subcommittee Chair Rep. Matt Rosendale, R-Mont., who in public hearings previously questioned the size of financial penalties imposed on Oracle Cerner for underperformance.

Commenting on the contract renegotiation, Dr. Neil Evans, acting program executive director of the electronic health record program, said: “These new accountability measures will be critical as we focus on improving system reliability and performance at the five sites that currently use the new EHR, as part of the larger program reset announced in April.”

“Specifically, the amended contract lays the groundwork for VA and Oracle Cerner to resolve the EHR issues identified by the “assess and address period” and optimize EHR configuration for future sites,” Evans added.  

Evans said the VA believes the new contract will give the agency the tools it needs to hold the technology company to account.

Since its rollout to five VA healthcare systems, the electronic health record platform has been hit with repeated outages and resulted in widespread complaints from frontline clinicians.

In a report published last year, an investigation by the department’s inspector general linked the system with at least six cases of catastrophic harm, including four deaths.

Commenting on the new contract extension, Oracle Global Industries Executive Vice President Mike Sicilia said: “This new agreement reflects Oracle’s commitment to Veterans’ health care as well as complete confidence in our technology and our partnership with the VA to deliver an EHR that far exceeds the expectations of users.”

Editor’s note, 5/16/23: This story was updated to include comment from Oracle.

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The bill, if it passes into law, would compel the VA to take a range of measures to reform the troubled EHR program, namely establishing program management within the Veterans Health Administration and reorganizing the management of the current reporting structure for the EHR functional champion and deputy CIO.

Details of the bipartisan proposal follow a raft of legislation introduced by lawmakers on both sides of the aisle seeking either to reform or abandon entirely the IT modernization program.

The legislation also calls to restrict the monetization or selling of veterans’ data by any internal or external entity conducting work for the VA

For the five VA medical centers currently operating the new EHR system, the bill would require the VA to ensure they meet or exceed performance baselines before taking the EHR live at any additional locations.

In addition, if VA and Oracle Cerner are unable to meet the requirements for the five sites within 180 days after enactment of the legislation, the bill would direct the agency to consider terminating or canceling the current contract.

The proposal was introduced by House Committee on Veterans Affairs Chairman Mike Bost, R-Ill., and Ranking Member Mark Takano, D-Calif. The House bill is companion legislation to the EHR Program RESET Act in the Senate, which is sponsored by Sen. Tester, D-Mont.

It comes after the VA last week announced that it would suspend the rollout of the Oracle Cerner-operated electronic health record system to any further locations as part of a program reset.

In a briefing at the time, the agency said the system will not be brought online at any further locations until it is “highly functioning” and issues at current locations are resolved, according to the VA. No timeline has been set for the continuation of the rollout.

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The top acquisition officer within the Department of Veterans Affairs (VA) and the national security contracting director at the Government Accountability Office (GAO) took particular aim at the Manage VA Act, proposed by House Democrats in March and the ‘Terminate VA’s EHRM Program’ proposed by House Republicans in January.

If enacted, the Manage VA Act would create a VA undersecretary for management post who would also serve as the Chief Management Officer (CMO). Democratic Rep. Mark Takano of California said the legislation and the new CMO role would have the effect of consolidating and standardizing acquisition and IT functions across the agency including improving the VA’s Oracle Cerner EHRM program.   

However, creating a CMO position within the VA is not a comprehensive solution on its own, Shelby Oakley, Director of Contracting and National Security Acquisitions at the GAO said during a House VA committee legislative hearing on Wednesday.

“Our prior work illustrates potential challenges that efforts to establish a VA CMO may face and that Congress should consider as a part of any legislative direction to VA,” Oakley said.

She added that efforts to establish a CMO position within the Defense Department provided “a cautionary example,” because the DOD was unable to fully address key issues such as how the CMO office would exercise authority and responsibilities vis-a-vis the CIO and furthermore the DOD did not commit funding to many of the cross-functional teams and reform initiatives which hindered ability of the CMO’ office ability to meet their goals.

“There needs to be much more discipline in the VA’s EHRM approach right now and it’s not clear that the CMO position would change that,” Oakley told FedScoop after the House VA legislative hearing. 

“It feels sometimes like the EHRM program is being run on ‘good vibes’ which just doesn’t work in the long run, we need better processes in place,” Oakley added.

The VA itself opposes the Manage VA Act because the agency said it has already established and continues to mature its joint oversight and decision-making roles and processes and a CMO role would be unnecessarily duplicative, said Phillip Christy, VA Deputy Chief Acquisition Officer.  

Furthermore, Christy and Oakley both said they oppose the Terminate VA’s EHRM Program bill because VA’s existing EHR system, VistA, which is 40 years old, is not a modern enterprise system that can provide a seamless experience for veterans, is not interoperable, and previous attempts to upgrade have failed.

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Cerner Enviza, an Oracle company, along with John Snow Labs, will help support the FDA’s drug safety Sentinel Initiative by using AI technology that will be used for two years to explore the possible mental health side effects arising from use of the asthma drug montelukast.

As part of the contract, the technology company will explore how machine learning and natural language processing can fill gaps in medical data collection. 

“This is an incredible opportunity to work with these exceptional leaders to use Oracle’s de-identified EHR data to help transform unstructured clinical notes into validated and useable data for physicians and researchers,” Mike Kelly, global head of Cerner Enviza said in a press release. “Connected technologies and unified data can accelerate innovation and, in turn, help providers realize better recommendations and outcomes for their patients.” 

The current manual methods for analyzing clinician notes can often prevent a full understanding of the symptoms and outcomes that patients experience at the population level but advances in artificial intelligence offer scalable and transportable natural language processing (NLP) systems, Cerner Enviza said.  

Cerner Enviza and John Snow Labs will together develop a new methodology to enhance computerized queries, or phenotyping, of digital patient data and clinical notes to support pharmacoepidemiology.

Cerner Enviza, was chosen to lead the contract by the Sentinel Innovation Center, who is headed by Mass General Brigham and Harvard Pilgrim Health Care Institute.

“Development and evaluation of tools that can enhance our ability to utilize unstructured EHR data is a key strategic priority for the Sentinel Innovation Center. We look forward to this new relationship and exciting initiative led by Cerner Enviza,” said Rishi Desai, Ph.D., Mass General Brigham executive leadership team member, Sentinel Innovation Center. 

The Sentinel Initiative is the FDA’s national electronic system for monitoring the safety of FDA-regulated medical products including drugs, vaccines, biologics and medical devices. It was launched in May 2008 in response to the passage of the FDA Amendments Act.

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The agency is seeking to introduce new penalty measures to its contract with the technology giant as part of discussions to exercise a five-year option for Oracle Cerner’s Millennium EHR platform.

“One of the key items we’re looking at is improving the frustration…around the limited enforcement mechanisms of the May 2018 contract. It’s very restrictive,” Michael Parrish, VA’s chief acquisition officer, told lawmakers at a Senate hearing earlier this week. “What we are renegotiating with the Oracle team is to strengthen and add more enforcement mechanisms especially around service level agreement.”

Concerns over the impact of the system on patient care have been expressed by frontline medical staff, lawmakers and oversight bodies. Earlier this year, the VA’s Office of Inspector General published a trio of reports that identified major concerns about care coordination, ticketing and medication management associated with the EHR program launch.

The implementation of the VA’s new EHR system is expected to be delayed from its original estimates by at least one to two years while the cost has ballooned by billions.

Sen. Jon Tester, D-Mt., the chairman of the Senate Veterans Affairs Committee, tore into Oracle Cerner during the Wednesday hearing saying that he wanted to see “tougher” terms in a renegotiated VA EHR contract with “severe penalties for poor performance.” Tester added that “if Oracle won’t agree to those terms, then the VA should be prepared to…renegotiate an entirely new contract or find a different team of partners.” 

Top House Republicans leading the charge to scrutinize the Oracle Cerner EHR system, like Rep. Matt Rosendale, R-MT., say the tech giant’s contract should be ended and the money returned to the government.

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Speaking at a Senate Committee on Veterans’ Affairs hearing focused on the future of the department’s EHR system, Sen. Richard Blumenthal, D-Conn., said his staff had been informed of the cases, of which four resulted in the death of veterans.

It is the first time that cases of catastrophic harm have been publicly linked to the VA’s electronic health record system since a watchdog report last July identified one case of such harm. The Veterans Health Administration (VHA) defines catastrophic harm as death or permanent loss of function.

“My staff was told yesterday that there were six catastrophic events related to a feature of the health record modernization program in the last couple of years,” Sen. Blumenthal said. “Four of the events resulted in a fatality, one for Spokane and three from Columbus, Ohio.”

Responding to a question, Dr. Neil Evans, chief officer for the Office of Connected Care within the VHA, said: “We take every episode where there is harm and we evaluate it carefully to try and understand why. It’s never good, we are never satisfied when it happens.”

“Yes, there have been cases that have found that frankly with both our EHR on the VistA side as well as with the Oracle Cerner EHR, that the EHR has been a potential contributor to that harm,” he said.

During the hearing, lawmakers expressed their exasperation about the continued failures of the VA’s electronic health record modernization program, which is built on Oracle Cerner’s Millennium platform.

Committee Ranking Member Sen. Moran, R-Kan., said lawmakers, the agency and Oracle Cerner needed to work together more effectively to solve problems with the system and questioned what criteria would be used to assess readiness as the VA looks to roll out the system to further locations in July.

“[W]e’re here again to discuss the challenges of the VA electronic health record modernization program,” Moran said. “I emphasize the word again – we’ve done this numerous times. The VA aims to create a unified health record for service members and veterans enabling more consistent health care.”

He added: “It’s frustrating that the opposite has happened. The five medical centers that are using this system are struggling with delays, disruptions and rising costs. Only yesterday we found out that the system has been a factor in the loss of veterans’ lives.”

Testifying at the hearing, Oracle executive Mike Sicilia defended the company’s track record of working to improve the medical records system since completing its acquisition of Cerner in June.

“When I last testified before you, Oracle was just over a month into its acquisition of Cerner. I made several commitments about adding resources, bringing new engineering and technical expertise, and making VA’s EHRM program Oracle’s most important priority,” Sicilia said. “Since then we have done that, and delivered significant improvements in a short amount of time. The technical fixes we have made to the system have resulted in meeting the 99.9% availability requirement in five of the last six months. Average downtime minutes dropped from 345 minutes per month prior to the acquisition to 21 minutes per month in January and February.”

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Montana Republican Rep. Matt Rosendale, who is chairman of the House Veterans’ Affairs Subcommittee on Technology Modernization, is bullish on removing Oracle Cerner’s EHR system and instead wants the VA to continue using its precursor, the Veterans Health Information Systems and Technology Architecture (VistA).

“If it was up to me, not only would Oracle Cerner be gone, but we would be clawing back some of the money that we’ve already spent on them,” Rosendale told FedScoop earlier this week during a brief interview after a hearing on the VistA and Oracle Cerner EHRs.

The Oracle Cerner EHR has faced grave performance issues since it was rolled out to five VA hospital locations in October 2020, with repeated outages that, according to the agency’s watchdog, have resulted in serious harm to veterans.

The implementation of the VA’s new EHR system is expected to be delayed from its original estimates by at least one to two years while the cost has ballooned by billions.

“If it’s up to Matt Rosendale, we would claw back every dollar from them,” the Republican said.
“We have a bill out there to terminate the Cerner contract but I think we should take it a step further. I do listen to the recommendations of my staff and so I haven’t done that but I think that they [Cerner] have done an absolute disservice.”

Instead, Rosendale said that the incumbent VistA EHR system still used in most VA hospitals today is much better than the Oracle Cerner system and could be improved and strengthened in certain ways if needed.

“Every time that I have the VA in front of me and the more information that I get, I get more convinced that VISTA is absolutely a system that can accommodate the needs of our veterans in the best fashion possible,” Rosendale told FedScoop.

“There’s not even a comparison between Oracle Cerner and VistA. When we’re talking about delivering safe, quality health care to their veterans, nobody can refute it. The numbers just don’t lie,” he said, referring to the high rates of dissatisfaction with the Oracle Cerner EHR system. 

Rosendale cited a recent survey of VA medical staff who use the Oracle Cerner EHR that showed 78% are dissatisfied. Meanwhile, Rosendale said over 70% of VA medical staff surveyed approve of the VistA EHR system.

Some Democrats, who are currently working on their own comprehensive legislation to fix the VA EHR, have argued that VistA is also plagued with its own issues including a lack of interoperability and nationwide access for veterans who change hospitals or move between states. 

Nevertheless, Rosendale, who has a history of slamming Oracle Cerner, said House Democrats have been very supportive in conversations with Republicans and during congressional hearings “in recognizing that Oracle Cerner is not delivering on the contractual promises that they made to us.”

During an interview with FedScoop in February, Oracle senior executives said the company would take a little less than a year to correct issues with the Cerner EHR system, after it acquired Cerner in June 2022, and said the IT giant would need another 9-12 months to right the ship. 

Oracle also highlighted that EHR system transitions, like the one from VistA to Oracle Cerner, are notoriously challenging and require significant training, culture adjustment, and major technical problem-solving. 

“The clock is running, now. Oracle has said they’ll come up the curve quickly within a year and time will tell,” Rep. Rosendale’s staff told FedScoop.

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