EHR vendor loses ONC certification for two of its records systems

This week health care organizations were startled and not a little concerned to learn of the ONC's unprecedented action with regards to a California health software company.  The agency is decertifying electronic health records systems which initially met ONC requirements for certification. 

Via Modern Healthcare:

For the first time, the Office of the National Coordinator for Health Information Technology at HHS has revoked certifications for two electronic health-record systems, raising troubling questions about how physicians and hospitals should react if the government nixes a system they're already using.

Federal officials require that doctors and hospitals use certified EHR systems in order to receive federal money to defray the cost of converting to EHRs. But on Thursday, the ONC said it decided to revoke certifications for two products on the market after anonymous complaints were lodged about the systems.

 

EHRMagic, of Santa Fe Springs, Calif., had two of its records systems shot down by the government: EHRMagic-Ambulatory and EHRMagic-Inpatient. Two people familiar with the company interviewed for this story said they were not surprised by the development, since the firm didn't seem able to live up to its promises on the sales side of the operation several years ago.

Calls and e-mails to EHRMagic on Thursday were not returned. Records with the California secretary of state list the 4-year-old company's corporate status as “suspended.”

ONC spokesman Peter Ashkenaz said no healthcare provider has “attested” to using the system, which means that no one had tried to receive federal funding to pay for installation of an EHRMagic system. Since 2011, more than 234,000 organizations and individuals have received a total of $12.7 billion in EHR incentives to install one of the 1,700 systems eligible for payments.

But a blog post Thursday from Carol Bean, director of the certification office at the ONC, makes clear that the office will continue aggressive monitoring for other EHR systems that don't meet the federal requirements. That includes proactive investigations and surveillance by the office, as well as inquiries that stem from tips from the public about shoddy systems.

“We want to be clear,” the blog post says, “the office of certification's role doesn't stop after EHR certification. We are also going to monitor certified EHRs to determine whether they continue to meet our requirements. The doctors, hospitals and other providers that are adopting—and have already adopted—EHRs deserve this and should feel confident that the tools they are using are up to the job of helping their patients get the best care possible.”

Ashkenaz declined to say what a healthcare provider should do if the system it is using ends up retroactively decertified for payments, as EHRMagic's systems were.

Richard Gant, CEO of physician-supply seller Innovative Healthcare Systems in Royal Palm Beach, Fla., said the EHRMagic situation pointed to another major concern about decertification. EHRMagic sells what is known as a “cloud-based” system, meaning that patient information is stored off-site and not physically in a provider's office.

“The biggest issue is, all of your information is on their servers,” he said. “And if they disappear, that information could go away.”

Several years ago, Gant's firm attempted to sell EHRMagic's systems through a sales model that would have allowed it to be installed for free in exchange for eventual federal subsidies. But he said Innovative Healthcare Systems severed its relationship with the EHRMagic after several initial attempts to install it failed, and sales payments were not forthcoming.

“When they weren't paying for anything and they weren't supporting clients of ours, we said goodbye,” Gant said. “I'm surprised they were even around to even be decertified.”

By Joe Carlson

ONC revokes firm's EHR certifications,” Modern Healthcare (April 25, 2013)

HHS Inspector General: Medicare EHR incentive program lacks adequate safeguards against error and fraud

The HHS Inspector General this week reported the results of its recent investigation to “verify the accuracy of professionals' and hospitals' self-reported meaningful-use information, as well as eligibility and payment amounts.”   The investigation reviewed payments issued from May through December 2011, a period during which approximately $1.7 billion was distributed to almost  28,000 recipients.  The Inspector General’s office concluded that Medicare needs to improve its review process.

Link to report here.

Via Modern Healthcare:

The CMS and the Office of the National Coordinator for Health Information Technology at HHS need to tighten up their oversight of the Medicare EHR incentive payment program, according to HHS' inspector general's office.
 
The watchdog office, headed by Inspector General Daniel Levinson, offered a couple of recommendations for the agencies in its report, "Early Assessment Finds That CMS Faces Obstacles in Overseeing the Medicare EHR Incentive Program" (PDF). The report is based on audits of EHR incentive payment attestations, reviews of internal CMS and ONC documents about the program and interviews with CMS personnel. The inspector general's office did not focus this time on the Medicaid portions of the program, although a previous report, issued in July 2011, did, focusing on 13 state-run Medicaid EHR incentive programs. The inspector general's office also is conducting "a series of audits of Medicare and Medicaid EHR incentive payments" to "verify the accuracy of professionals' and hospitals' self-reported meaningful-use information, as well as eligibility and payment amounts. No time frame for those audits was included in the report.

The inspector general's review covered the early stages of the Medicare EHR incentive program, from when payments started flowing in May 2011 through December 2011. During that period, the program paid out about $1.7 billion to nearly 27,000 physicians and other eligible professionals and 668 hospitals, the report said. 
 
The inspector general said that the CMS validates the presence of some required information and confirms some calculations provided by hospitals and providers. For example, "The validation checks that self-reported numerators and denominators calculate to required percentage thresholds and that all relevant yes/no measures were checked 'yes,' " according to the report. However, the report continued, the CMS "does not verify that numerators and denominators entered for percentage-based measures reflect the actual number of patients for a given measure or that professionals and hospitals possess certified EHR technology."
 
One "obstacle" the CMS faces in trying to get independent validation that what the providers are attesting to actually happened is that data from other sources—such as Medicare claims or private insurance data—is either incomplete for the task or unavailable.
 
The inspector general's office notes that although the CMS is not required to perform prepayment verification, "doing so would strengthen its oversight of the anticipated $6.6 billion in incentive payments" the program is expected to shell out over its lifetime, which runs through 2016.
 
Regarding post-payment oversight, the inspector general noted that, so far, the CMS "has not yet completed any post-payment audits." But the CMS has said it plans to use EHR-generated reports "to verify the accuracy of self-reported information where possible" and obtain supporting documents in instances where the reports don't cover the audit subject matter—and this is where the ONC comes in for criticism.
 
The ONC oversees the rule writing, and the testing and certification programs to determine whether EHR technology qualifies for use in the Medicare EHR incentive payment program.
 
The CMS "cannot use EHR reports to verify all self-reported meaningful-use information because ONC does not require certified EHR technology to be capable of producing reports for all meaningful-use measures," the inspector general's report said. The ONC requires an EHR to write reports on the 30 percentage-based measures but not the 19 yes/no measures users also are required to attest to in order to get paid.
 
"EHR reports also do not contain information necessary for CMS to verify all percentage-based measures," the inspector general's report said, specifically noting that denominators for many of those measures include data from both paper-based and EHR systems.
 
The inspector general's office recommended that the CMS beef up its prepayment assessment program, including by focusing on "high-risk" professionals and hospitals, asking them to "submit supporting documentation for prepayment review."
 
It also recommended that ONC "improve the certification process" to ensure that certification bodies "comprehensively test EHR reports for accuracy as part of the certification process" as well as not rely on "vendor-supplied data" during the testing phase.
 
The CMS, in an Oct. 9 letter from acting Administrator Marilyn Tavenner, said prepayment audits were not necessary at this time, but concurred with another inspector general's office recommendation to issue a guidance on proper provider documentation required for the program.
 
In a similar letter to the inspector general's office dated Sept. 25, ONC chief Dr. Farzad Mostashari concurred with the inspector general's office's recommendation of testing a "yes/no" reporting functionality. He said he would ask his two advisory committees, the Health IT Policy and Standards committees, to make recommendations "on the appropriate scope and feasibility of a certification criterion focused on 'yes/no' reports."
 
Mostashari also said the ONC has “already taken steps” to address a separate inspector general's recommendation that it improve its EHR testing and certification program. Specifically, the OIG recommended that the national coordinator supplant vendor-supplied data used in the initial rounds of its certification tests with a standard data set to be used by all vendors.
 
Last fall, GE warned customers of two of its EHR systems for ambulatory-care providers that errors had been found in reports to support meaningful-use attestations. That incident was specifically mentioned in the OIG report, which added that the ONC's certification process "did not identify these potential inaccuracies because the vendor-supplied test data did not account for the manner in which some professionals use the products." Similar problems may exist with reports from other EHR products, the OIG report said, but it cited no other examples of report-writing failures.
 
In his letter, Mostashari said the updated 2014 edition testing and certification rules—which were released in February in conjunction with the CMS' Stage 2 meaningful-use rules—contain "more rigorous testing requirements" that became effective Oct. 4, 2012. He said the ONC "will continue to migrate away from the exclusive use of vendor-supplied data."
 
In a telephone interview, Mostashari said the GE report-writing problem was "old news." Asked whether he was aware of any other incidents of EHR systems failing to produce accurate test reports, Mostashari said, "It's really a CMS question."

By Joseph Conn

HHS inspector general: Medicare EHR program needs better oversight,Modern Healthcare  (November 29, 2012)

ONC: no caps on per-provider EHR incentive payments

National Coordinator for Health IT Farzad Mostashari has announced there is no cap on how much individual providers may receive in meaningful use incentive payouts, as long as they meet the requirements for the EHR incentive payments program.  According to the ONC, almost seven billion of the approximately twenty billion dollars in incentives allocated under the HITECH Act has already been distributed.

Via Healthcare IT News:

WASHINGTON – There are no set appropriations for how much the federal government can spend on rewarding providers who adopt and use electronic health records under the Medicare and Medicaid meaningful use EHR incentive program, according to National Coordinator for Health IT Farzad Mostashari, MD.

"Whoever qualifies, gets paid; there's no hard cap," said Mostashari, who gave a keynote at the Annual Policy Summit for the Health Information Management and Systems Society (HIMSS) on Wednesday.

Mostashari said the federal government estimates it will pay out around $20 billion in incentives before the program shifts to a penalty in 2015, but there is no fixed budget set in the HITECH Act that mandated the program. The government recently announced it has paid out nearly $7 billion since the program began in 2011.

[See also: "Government EHR incentives near $7B."]
 

The federal health IT czar said he couldn't imagine health IT advancement – which enjoys widespread bipartisan support – losing the backing of Congress after the election, no matter the party in control.

It would be hard to picture Congress cutting or capping the program after doctors and hospitals have made major investments in health IT "on the good word of Congress," he said.

An attendee of the HIMSS Policy Summit – a sort of pep rally for HIMSS members to promote HIT on the Hill – recommended that Congress all be encouraged to use Blue Button to access their personal health data. This would "crystallize quite clearly" where things stand with regard to health IT today. We need more time and support, the attendee said, and Mostashari and other attendees agreed.

Mostashari praised the meaningful use incentive program, noting that "we've made great steps." He predicted that Stage 2, set to begin in 2014, will bring about even more "incredible progress."

The use of electronic health records is "ultimately about population health," Mostashari said. "You have to care more about the people who didn't walk into your door, than those who did." The meaningful use program is intended to go from measuring quality at the start, to accounting for population health. "That's why doctors are doing what they're doing, [and] that's why we're doing what we're doing," he said of federal regulators.

At a visit to the Cleveland Clinic recently, Mostashari said he observed health data exchanged between the clinic and other local facilities, using compatible coding that transferred the data easily. "They do it all day, every day," he said. "So don't tell us that exchange isn't happening."

[See also: "Stage 2 MU released at last."]

Two years ago, the industry wasn't there, he said of health information exchange. The patient information wasn't packaged and ready to code medications and lab reports in the same record. But things have changed, Mostashari added. He praised the industry and the  marketplace for pushing it forward.

The industry came together with a consensus and pilots and working groups, which resulted in the meaningful use Stage 2 rule, Mostashari said. "We're light years ahead of where we could possibly have been in Stage 1," he added, noting that he believes meaningful use Stage 2 will necessitate a push from the industry for health information exchange standards.

It will be important in the near future to tap into "the biggest underused resource – the patient," Mostashari said. Providers will have to "be sticky," and attract patients to their services because patients will no longer be limited to the provider that holds their health information.

Said Mostashari, speaking to doctors as a doctor: "We have to make them want to come to us."

By Diana Manos, Senior Editor

Mostashari: No cap on EHR incentive payouts,” Healthcare IT News (September 13, 2012)

ONC announces five organizations to serve as EHR certifiers

In preparation for the launching of ONC's permanent EHR system testing and certification program, part of the EHR incentive payment initiative, ONC has authorized five groups as permanent EHR certifiers.

Via Modern Healthcare:

Even though the new regime for testing and certifying electronic health-record systems under the federal EHR incentive program won't take effect until October—and testing against newly released criteria might not begin until year's end—federal authorities have given five organizations the OK to certify software for that program.

HHS' Office of the National Coordinator for Health Information Technology has authorized the Certification Commission for Health Information Technology, the Drummond Group, ICSA Labs, InfoGard Laboratories and Orion Register to serve as certification bodies under the EHR incentive payment program, according to ONC spokesman Peter Ashkenaz. The program was established by the American Recovery and Reinvestment Act.

 

C. Sue Reber, spokeswoman for one of the five, the Chicago-based CCHIT, said the news came in a conference call with the ONC on Tuesday.

In July, all five organizations were accredited by the American National Standards Institute as certification bodies and by the National Voluntary Laboratory Accreditation Program as accredited testing laboratories for EHR systems.

Back in January 2011, the ONC published a final rule creating permanent and separate EHR testing and certification programs for the incentive payment programs run by Medicare and state Medicaid agencies. The permanent programs replace a temporary testing and certification regime set up to get the EHR incentive program off the ground. Under the temporary program, EHR testing and certification functions were combined and performed by the same organizations.

Under the new regime, it is still possible for the same organization to perform both testing and certification, but the procedures to receive authorization to do both are now separate, and the organizations must maintain a "firewall" between those functions, according to the ONC, which has an explanation of the program on its website.

CCHIT will continue to offer testing and certification services under the temporary program until the Oct. 4 effective date of the permanent program, and after that will continue to test and certify systems under the initial, Stage 1 certification criteria.

New testing and certification criteria for what's being called the 2014 edition were released in a new final rule by ONC last week. CCHIT said it would incorporate those new criteria into its programs "as soon as ONC releases approved testing procedures," which are expected to be available at the end of the year.

"Five groups named permanent EHR certifiers", Modern Healthcare (August 29, 2012)

HHS awards over $650 million in EHR incentive payments

HHS released the first numbers regarding its Meaningful Use incentives program, established by the HITECH Act of 2009. Unsurprisingly, most eligible professionals and hospitals receiving funds this year qualified for incentive payments under Medicaid, rather than Medicare, because Medicare has a higher threshold for receiving such payments. Medicare requires the eligible professional or hospital to achieve and demonstrate meaningful use, while Medicaid mandates only adoption, implementation or upgrade of existing systems. 

Nevertheless, the extent of the disparity was somewhat surprising: only about 6% of eligible hospitals and 3% of eligible professionals qualified for meaningful use incentives under Medicare.  Via Modern Healthcare:

So far, Medicaid program payments for hospitals, physicians and other eligible professionals that have adopted, implemented or upgraded to a certified EHR system have totaled $389 million. Only $264 million has been paid under the Medicare program, which has a higher eligibility threshold, requiring providers to demonstrate that they are meaningfully using their certified EHR system.

 Through Aug. 31, 2,054 hospitals have registered with the CMS to receive Medicare incentive payments. Hospitals that registered as dual-eligibles need to attest to having met meaningful-use targets under the Medicare portion of the program. But only 114 of the registered hospitals—less than 6%—have attested to being meaningful users. They have split about $226 million in Medicare EHR incentive payments.

Similarly, for the same period, 71,378 physicians and other "eligible professionals" have registered with the CMS under the Medicare EHR program, but only 2,129—or about 3%—have shared in $38.3 million in Medicare EHR payments. Unlike hospitals, professionals can't participate in both the Medicare and the Medicaid incentive programs. They must choose one.

According to the CMS, 15 hospitals have been paid solely under state-run Medicaid programs; they have received $32.9 million. In addition, 294 hospitals registered as dual-eligibles have been paid $262.2 million by Medicaid. There have been 4,463 physicians and eligible providers paid $93.9 million under Medicaid, according to the CMS.

You can find the CMS summary and charts relating to EHR incentive payments by clicking here.

"CMS: $653 million in EHR incentives paid," Modern Healthcare (September 22, 2011).
 

 

GOP bill proposes repeal of HITECH Act

 Via Healthcare IT News:

The Spending Reduction Act of 2011 (H.R. 408), introduced on January 24 by Rep. Jim Jordan (R-Ohio), seeks to reduce federal spending by $2.5 trillion over the coming decade. As it does so, it singles out many federal programs for elimination.

Section 302 of the bill, titled "REPEAL OF CERTAIN STIMULUS PROVISIONS," states that "effective on the date of the enactment of this Act, subtitles B and C of title II and titles III through VII of division B of the American Recovery and Reinvestment Act of 2009 (Public Law 111-5) are repealed, and the provisions of law amended or repealed by such provisions of division B are restored or revived as if such provisions of division B had not been enacted."

Since the Medicare and Medicaid EHR Incentive Programs set up under the ARRA/HITECH Act of 2009 fall under division B, it would appear that the $27 billion earmarked for disbursement to healthcare providers to spurring EHR adoption would fall on the chopping block were the bill to ever pass.

For good measure, Jordan's Republican Study Committee also decrees that the enacted legislation would "further prohibit any FY 2011 funding from being used to carry out any provision of the Democrat government takeover of health care, or to defend the health care law against any lawsuit challenging any provision of the act.

 

 Of course, the measure has little chance of succeeding, considering it would have to pass the House of Representatives, the Senate, and avoid an almost-certain veto from President Obama. Still, the GOP-backed proposal does add a bit of uncertainty in the market.  

Dave Roberts, vice president of government relations for HIMSS, is less worried about the bill being signed into law than he is about the climate it creates.

The draft has already been referred to 14 different committees in the House, he says, so it's going to be a while before it sees any floor action.

The problem is that it's already "creating confusion in the industry," says Roberts. "We've heard from some CIOs, asking us, 'What is this? We hear the House is going to rescind our money.' It adds to the confusion in the whole marketplace. And providers and hospitals who want to purchase this [technology] are wondering, 'Do I really want to start down this path?'

"We're trying to tell people," he says, "that this process is going on. This is only one body [of Congress]. Don't let this be a concern."

But, Roberts cautions: "We're leading up to the 2012 elections. The Senate's majority is very reduced right now. And if this is a new way of thinking, that could be concerning. So I think that while this particular bill may not pass, it's something that has to be watched closely.

HIMSS has issued a Legislative Action Alert on January 25, 2011. As a strong proponent of the EHR incentives program included in the HITECH Act, there is little doubt that HIMSS will be quite engaged in defending this portion of the stimulus bill.

"GOP-sponsored bill threatens MU funding," Healthcare IT News (January 28, 2011).

 

Registration for CMS EHR Incentive program is now open

Center for Medicare and Medicaid Services (CMS) opened the registration process for eligible hospitals and professionals hoping to capitalize on the incentive payments provided under the HITECH Act.  Each such hospital or professional needs to register with CMS in order to receive such payments, and CMS encourages all eligible healthcare providers to register as soon as possible.

You can find the EHR Incentives Program registration page by clicking here.

According to Government Health IT, over 4,000 providers have already registered with CMS. Several states have also launched registrations for their Medicaid incentive programs.  Moreover, hospitals in Oklahoma and Kentucky have already begun receiving incentive payments:

Kentucky processed payment to the University of Kentucky Healthcare, the university’s teaching hospital, for $2.86 million. The first payment amounts to one- third of the hospital’s overall expected amount for participating in the program, according to CMS. Oklahoma issued payments to two physicians at the Gastorf Family Clinic of Durant, Okla., for $21,250 each for having adopted certified EHRs.

Besides Kentucky and Oklahoma, registration is available for the Medicaid EHR incentive program in Alaska, Iowa, Louisiana, Michigan, Mississippi, North Carolina, South Carolina, Tennessee and Texas.

In February, registration will open in California, Missouri, and North Dakota. Other states will likely launch their Medicaid EHR incentive programs during the spring and summer of 2011.

You can learn more about registration for Medicare incentives for eligible professionals by clicking here; and for Medicaid incentives for eligible professionals by clicking here. A similar CMS guide for both Medicare and Medicaid incentives for eligible hospitals can be found here.