Posted on 12/31/2019 3:31:47 PM PST by spintreebob
The federal government funneled billions in subsidies to software vendors who overstated or deceived the government about what their products could do, according to whistleblowers.(LYDIA ZURAW/KHN)
This story also ran on Fortune. This story can be republished for free (details).
Derek Lewis was working as an electronic health records specialist for the nation’s largest hospital chain when he heard about software defects that might even “kill a patient.”
The doctors at Midwest (City) Regional Medical Center in Oklahoma worried that the software failed to track some drug prescriptions or dosages properly, posing a “huge safety concern,” Lewis said. Lewis cited the alleged safety hazards in a whistleblower lawsuit that he and another former employee of Community Health Systems (CHS) filed against the Tennessee-based hospital chain in 2018.
The suit alleges that the company, which had $14 billion in annual revenue in 2018, obtained millions of dollars in federal subsidies fraudulently by covering up dangerous flaws in these systems at the Oklahoma hospital and more than 120 others it owned or operated at the time.
The whistleblowers also allege that Medhost, the Tennessee firm that developed the software, concealed defects during government-mandated reviews that were supposed to ensure safety.
Both CHS and Medhost have denied the allegations and moved to dismiss the suit. The motions are pending. Last month, Department of Justice lawyers wrote in court filings that they were still investigating the matter and had not yet decided whether to take over the case.
The lawsuit is one of dozens filed by whistleblowers, doctors and hospitals alleging that some electronic health records (EHR) software used in hospitals and medical offices has hidden flaws that may pose a danger to patients — and that a substantial chunk of the $38 billion in federal subsidies went to companies that deceived the government about the quality of their products, an ongoing Fortune-KHN investigation shows. The subsidies were designed to persuade hospitals and doctors’ offices to install software that would track the medical history of every patient and share the information seamlessly with other health care providers.
But the software makers allegedly gamed the system, repeatedly. Three major EHR vendors have made multimillion-dollar settlement deals — totaling $357 million — over Justice Department investigations which include allegations that they rigged or otherwise gamed the government’s certification test. At least two other companies are under investigation.
Beyond those cases, federal officials have paid hundreds of millions of dollars in subsidies to doctors and hospitals that could not show they were even qualified to receive them, according to federal officials. Nearly 28% of doctors and 5% of hospitals who attested to meeting government standards later failed audits. Federal officials told Fortune and KHN that they have clawed back $941 million in improper subsidies.
“We’re entering an entirely new area of health care fraud,” John O’Brien, senior counsel with the Department of Health and Human Services Office of Inspector General, said in a July 2017 video announcing a $155 million False Claims Act settlement with eClinicalWorks, one of the nation’s leading sellers of EHRs for physicians.
The concern is not just over wasteful spending of tax dollars. EHRs monitor the medicines people take and their vital signs, so software glitches that prevent doctors from accessing files quickly, that mix up patients or send vital test results to the wrong file can contribute to serious injuries, or even deaths.
In March, Fortune and KHN revealed that thousands of injuries, deaths or near misses tied to software defects, user errors and other problems have piled up in various government-sponsored and private repositories.
“Ultimately, it’s about patients getting the right care,” Andrew Vanlandingham, the HHS inspector general’s senior counselor for health information technology, said in an interview. He said that investigators are “gearing up” for more scrutiny of the important industry, including closer monitoring to make sure that records software is safe.
The Justice Department accused eClinicalWorks, an EHR company whose medical software is used by 130,000 providers, of rigging the government’s certification test, claims the company has denied. eCW settled the case for $155 million in 2017. Leaping Into The Digital Era
In 2009, Congress committed billions of dollars in economic stimulus funds to bring the era of paper medical records to a close. Officials hoped to cut down on medical errors caused by illegible paper records and draw on the power of massive troves of medical data to drive down the cost of health care and help develop improved treatments for disease.
The hastily devised plan offered Medicare doctors and other medical professionals up to $44,000 and $64,000 in subsidies if they bought the software and accepted patients on Medicaid, the federal health care program for low-income people.
The money was intended to help them pay vendors to install EHRs in their offices. Hospitals, which required more sophisticated and costlier software, could receive millions in subsidies, based on the number of inpatients treated. To give them a nudge, officials warned doctors and hospitals that failure to wire up would trigger gradual cuts in their Medicare payments. EHR vendors had to meet certification standards set by the HHS Office of the National Coordinator for Health Information Technology, or ONC.
Providers had to attest that their EHR software could perform a variety of functions, which the government described as making “meaningful use” of the technology.
Certification was essentially an open-book test in which the government gave vendors the questions in advance — for instance, the names of 16 or so drugs the system would have to prescribe electronically to pass. The Justice Department has alleged that some vendors simply doctored their software to pass the test — for example, programming the required codes for just the specified 16 drugs they would be tested on, rather than all medicines — as officials had expected.
Frank Poggio who recently retired from a 45-year career in health technology, saw the cases of fraud coming, he said, because the tests “were superficial, and if you wanted to game it, you could game it.”
Poggio said there were many weaknesses in the system that allowed a vendor to show a “prototype” as opposed to live software.
Dr. Scott Monteith, a Michigan psychiatrist who served as an early certification juror, said he saw some limitations firsthand. He said one vendor took 30 minutes to produce a list of patients who had diabetes and also smoked, data he figured any computer program should be able to spit out in seconds. The vendor passed.
“That’s an example of how poorly thought-out the whole thing was,” said Monteith, who noted he was then, and still is, a big booster of EHRs.
Jeffery Daigrepont, a senior vice president at Coker Group, a firm that advises health providers on business decisions, said the government erred by handing out too much money in the early stages of the program, when many doctors and hospitals had not yet done much more than agree to participate.
“It was an upside-down pyramid,” he said. “You got the bulk of the money for doing the least amount of effort.”
Dr. John Halamka, a physician and Harvard Medical School professor who chaired the ONC standards committee, which wrote the certification rules, defended the process.
“The only problem [with certification] is that it presupposed that the product the vendor certified would be the same product they sold,” Halamka said. “It presupposes that people will go into the certification process and participate in good faith.”
That did not always happen in the rush to snatch up subsidy dollars, according to the whistleblowers’ suits. The Justice Department case against eClinicalWorks, which has 130,000 providers, accused the company of rigging tests to win certification, claims the company has denied. The company did not respond to numerous requests for comment.
The government accused Greenway Health, a Florida-based EHR developer with 75,000 providers, of doing the same thing. The DOJ’s complaint included a number of instant-message exchanges between Greenway employees in which they allegedly discuss their plan for gaming the certification process by “shortcutting some functionality” of the software. In February, Greenway Health settled with the government for just over $57 million without admitting wrongdoing.
The whistleblower case filed by Lewis and former co-worker Joey Neiman accuses the CHS hospital chain of submitting more than $385 million in false claims for EHR stimulus payments between 2012 and 2014.
The government accused Greenway Health, a Florida-based electronic health records company, of gaming the government’s certification process. In 2019, the company settled those allegations for $57.25 million without admitting wrongdoing.
Visiting the Oklahoma hospital as part of a troubleshooting team in June 2015, Lewis heard that physicians worried flaws in the system could result in patients being sent home “with the wrong drugs, doses or instructions,” according to the suit.
Things got so bad that local doctors were threatening to admit patients elsewhere unless the hospital fixed the software problems, according to the suit.
In a statement, CHS said it had “complete confidence” in its records systems. “The allegations made in the lawsuit against our hospitals are completely without merit,” the company said. Medhost denied its software has flaws, noting in its statement: “Hundreds of facilities have successfully used our software over the years and continue to do so today.”
Few in the industry seemed surprised by such allegations. When news of the eClinicalWorks case broke, Farzad Mostashari, who led the ONC from 2011 to 2013, tweeted: “Let me be plain-spoken. eClinicalWorks is not the only EHR vendor who ‘flouted certification/misled’ customers. Other vendors better clean up.”
The Electronic Health Record Association, a trade group that represents more than 30 vendors, did not respond to a request for comment. However, vendors have argued that they faced a tangle of regulations that required them to meet constantly shifting standards that government officials often could not explain.
ONC officials declined to answer written questions. But in a statement, ONC said it takes steps to ensure that products “are safe for patients and usable by providers.” ystem Glitches And Accusations Of ‘Gaming’ The System
While the ONC sets the standards, the federal Centers for Medicare & Medicaid Services (CMS) had the job of paying doctors and hospitals that attested to meeting the “meaningful use” criteria. As of September 2018, CMS had paid out $38.4 billion in these funds.
In 2012, CMS hired accounting firm Figliozzi and Co. of Garden City, N.Y., which audited almost 50,000 medical professionals. Nearly 28% failed, despite the fact that they had previously attested to meeting the standards. Hospitals did better, posting a 5% failure rate. CMS officials said they have recovered some $941 million in these improper payments. The losses to the Treasury are likely far higher because only 14% of the medical professionals and 40% of the hospitals receiving payments were audited.
Hamstrung By Technology?
ONC officials said they keep no log of complaints they receive.
A study published in JAMA this month found that 40% of the software that ONC singled out for post-marketing review had flaws that could lead to patient harm, including inaccurate drug codes, information displaying incorrectly and decimal points gone missing.
That’s “a concerning number, and we have to do something to address that,” said researcher Raj Ratwani, the director of the MedStar Health National Center for Human Factors in Healthcare and a co-author of the study. These systems were used in 786 hospitals and by 37,365 provider organizations, according to Ratwani, who said there’s no way to know how many defects have been fixed.
ONC has “decertified” about 100 pieces of once-approved software products. But most were tiny market players that had few or no users and went out of business. PlatinumMD, which had just 48 “meaningful” users, is an example. In a 2014 whistleblower lawsuit, San Diego urologist Dr. Scott Brown alleged that PlatinumMD filed for $18,000 in subsidies on his behalf even though it had not yet fully installed his EHR. In February 2016, the defunct company’s owners settled the case without admitting liability by paying the government $180,000.
Another 132 government-certified products have been flagged for corrective action due to “non-conformities.” As for the technology that the government alleges was fraudulently certified, it’s still used in health care settings across the country.
While those vendors faced multimillion-dollar settlements and now must operate under the oversight of a government monitor, their technology was not taken off the market. Nor were they dumped by many customers who, for the most part, however dissatisfied, were stuck with it.
ONC seemed to acknowledge that decertifying a large vendor would cause a major disruption, noting in an October 2016 regulation: “Our first and foremost desire would be to work with developers to address any problems.”
In the regulations, ONC cited the costs medical providers would face should their EHR vendor shut down as ranging from $33,000 to as much as $650 million.
“It is very difficult to switch product,” said Steve Waldren, chief medical informatics officer for the American Academy of Family Physicians. “You couldn’t just go down the street and pick up another EHR, put it in and move your data over.”
He noted that beyond the considerable cost of the technology, providers would have to take time to learn a new system.
“ONC does seem to have a stance that removing some of these players from the market would be very disruptive,” said Brad Ulrich, a Tennessee health IT expert. “They are almost too big to fail.”
Sorry “Employee” not “Employer”
The physical record belongs to the doctor.
The information in it belongs to you.
The Federalist recently had an article about this.
The EHR is a catastrophic error!
Check out Rand Paul’s fight against the National Patient Identifier. There is a lot more than just guns at stake.
The big push now is to collect SDOH Social Determinants 0f Health.
What criteria do you think will be collected as the SDOH of Mental Illness?
The Pre-Cogs of Tom Cruise are about to place their dreams in the database. When the next Richard Jewell becomes a suspect, his name will already be in the database with SDOH data to point to his guilt.
Separate from the ACA, Obama and the Pubbies in Congress passed the HITECH ACT which funded many billions for EHR. It had very elaborate regulations. Those who wrote the regulations were still living in the FAT CLIENT era of failed technology that was biased to be anti-mainframe.
Many young developers, both on shore and off shore were hired to develop the HITECH software and learned that was the way to do it.
Then, Obama and the Pubbies wrote and passed the CURES Act, which resulted in many regulations that totally contradicted the HITECH regulations.
The contradiction the industry is concerned about in INTEOPERABILITY... the ability for other doctors and hospitals and other payers to be able to access the data across all databases.
Not only are the two non-Obamacare bills wasting hundreds of billions of taxpayer money because the swamp cannot make up its mind, but they are building a mess that intentionally has so many backdoors it looks like a house of horrors.
Never believe a plaintiff’s lawyer. His goal is extracting personal financial gain by lying to a gullible jury.
The computerized health records available to patients at password protected sites are a boon to maintaining one’s wellness. Those who are ignorant and lazy will not benefit, but that is their problem and not the fault of the available records. .
Don’t blame JUST those in India. The same Indians are in the US working for EPIC, CERNER, IBM Watson Health, DeLoitte, Siemens and hundreds of others like them.
And don’t blame JUST the Indians. The Americans are just as incompetent, and just as unconcerned about quality as anyoneelse.
IT workers in the Government Sector have far lower standards, lower expectations, than those working for State Farm or Allstate type shops that are very similar in nature of the IT software and hardware.
UHC, Humana, BCBS seem to have mid-level quality, far worse than State Farm and Allstate, but maybe a little above the ONC of CMS of HHS.
You may have hit the nail on the head. The regulations and young developers are all focused on websites. There is no attention or understanding of the databases and backend processing needed support the websites.
It is GIGO. But they are obsessed with pretty VISUALIZATION of the Garbage.
it starts with good-ole-boy networks
It started when Cain created the Brother’s Keeper Paradigm.
God Asked Cain a question. Cain did not like God’s question, nor the answer. So Cain created a new way of looking at things rather than God’s way. Cain created the Brother’s Keeper view of the world.
God had created the Brother’s Brother view of the world.
Brother’s Keepers know best what is in your own self-interest and will tax you to impose it on you.
Republican Congresses appropriated that money after 2010 .... in addition to the Democrat Congresses of 2007-2010.
Michelle was a lawyer for the University of Chicago Healthcare System. It was her job to find the loopholes so her employer could get the moneey without going to jail.
Or, you can seek out a physicians group and insurer with good electronic record keeping that enables you to see your current records and those over time. That keep track of appointments and current perscriptions and allow confidential communication
If your physicians and specialist groups lack the ability, you need different providers
Typos and fat finger is one thing. Incompetent regulators is another.
Sub-agencies of HHS have 3 different sets of race codes. I am either Caucasian, or White or 1 depending on which agency you ask. My co-worker is either African-American or Black or 2. Native Americans, Native Hawaiins, Native Alaskans have so many code alternatives they could be anything.
The result is that when the data moves from one system to another system, the receiving system does not recognize the code and defaults to UNKNOWN.
So why collect the codes when 80% ends up as UNKNOWN?
Sex, Gender, Gender-self-identity is even worse. Nobody can agreed on the codes. New identities are being discovered all the time.
The wrong sex code could (including UNKNOWN) could trigger someone... as likely trigger the PC health worker as the patient.
DH and I went to our PCP the other day for the Medicare annual “Wellness Exam”. He was all excited, believing it would be a free physical exam. I told him it wasn’t, because the ladies in my quilting group had given me a heads-up. Still, he was thinking “physical”.
So my appointment was first. Doc is going down the list of questions asking if we had area rugs in the house, if we had smoke detectors (I knew the gun questions was coming soon), and I started to laugh. I said, “You don’t need to know that. This isn’t medical; it data harvesting for the government.” That that was the end of that.
Hubby was next. When he came out I saw the look on his face. He had told her the exact same thing and, boy, was he pissed. I laughed; I had warned him. NOT a physical.
So if you’re going for your annual WELLNESS exam, be forewarned.
On what do you base this assessment?
Government contractors have specialization. One department does nothing but respond to RFPs with Proposals. They are totally separate from the Department of the same company that implements that contract if they win the contract vs the competitors.
Of course, many sub-contractors are involved also.
For a data warehouse My government shop started with RFIs and identified 23+ potential contractors for a $100 million contract. We narrowed it down to 16, then 13, then 9, 7 and 5 and finally 2 and the 1... the winner for $100 million.
Included in the bidders were 5 or 6 companies that had existing contracts to create part of the data that would go into the new data warehouse. Included in the bidders were the companies the managed the 3 existing data warehouses that we wanted merged into 1 data warehouse that was new and improved over the existing.
One company that was the #1 supplier of informatiion to the existing data warehouses and created and managed one of the data warehouses submitted a proposal that was the worst of the top 7. Whoever wrote that proposal was incompetent.
Yet I know some of the workers in the trenches for that company who are far more competent than was revealed in their proposal.
The company whose proposal ranked #2 in quality was written by someone who really understood what we needed and wanted. It was probably written by one of their small subcontractors as the prime contractor suggested a joint venture with several sub-contractors.
So the companies with the #1 and #2 Proposals were in a bakeoff for the winner and required to answer additional questions and clarifications. Whoever was assigned to write the response to the bakeoff for Company #2 was totally incompetent. Their answers were like those of a high school sophmore.
The result was that company that had the #1 proposal won the contract. It took years to go through the “Protest Period” where any of the 7 losers could protest the process, and the substance on any real or imagined grounds. Then for the lawyers for each side to draw up the contract fine print.
Remember, this is happening while the government is changing and contradicting itself with regulations.... and technology is rapidly changing.
So May 2018 the $100 million project actually started. The winner hired a total of about 100 people. As many as 75 on the project at any one time. The single largest group was natural born Americans. But there were significant numbers on naturalized citizens and non-citizens also. (I didn’t know everybody on the project well enough to know their status.)
8 of the top 10 leaders/bosses were natural born citizens. None of the top 10 had the slightest idea how to design and build the data warehouse. None of the 10 had been involved in writing the proposal. A couple of the 10 had been on the Colorado Project earlier but apparently were unable to learn from the mistakes made on that project.
From May 2018 to Aug 2019 we tried to get the winning bidder to get it together and start designing and building the data warehouse. After 15 or 16 months we gave up and cancelled the contract.
Nobody broke the law. Nobody can go to jail. Incompetence is not illegal.
(PS of the 100 people hired there may have been 5 or 6 down in the trenches who actually were competent. But leadership did not listen to them and bluntly told them that they were not leadership and their comments not welcome.)
On occasional communication with them. (I used to work for BCBS, State Farm and Allstate ... and 35 shops not mentioned.)
And on seeing the quality of their data that goes into my data warehouses.
In terms of data quality, State Farm and Allstate would fire anyone who produced the quality of any of the others listed.
When the quality of the data is so poor, what makes them a boon?
What level of quality would you accept as a boon?
If my shop, or a hospital, has access to data on a million people and the data is wrong on allegies to medicines in some how many errors are acceptable?
1 in a million? 1 in 100,000? 1 in 100? 1 in 10?
When determining how much taxpayer money goes where, what level of data quality is acceptable?
Let’s spend taxpayer money on Maternal and Infant death. What level of data quality is acceptable to design the program and actually have a positive effect on the death rate?
The quality of the data is a function of the data provider. If your data is bad, it is your task to find a different provider.
I deal with several providers that all have excellent electronic records that allow me to know the status of my health as currently established.
Laziness is the culprit. To access and actually use the data, you must spend some time and effort. Or, in a state of laziness you can try to remember and disremember what you think you were told.
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