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FDA chief calls for stricter scrutiny of electronic health records
“What we really need is a much more tailored approach, so that we have appropriate oversight of EHRs when they’re doing things that could create risk for patients,” Dr. Gottlieb said in an interview with Kaiser Health News.
Dr. Gottlieb was responding to “Botched Operation,” a report published March 18 by KHN and Fortune magazine. The investigation found that the federal government has spent more than $36 billion over the past 10 years to switch doctors and hospitals from paper to digital records systems. In that time, thousands of reports of deaths, injuries, and near misses linked to EHRs have piled up in databases – including at least one run by the FDA.
Dr. Gottlieb said Congress would need to enact legislation to define when an EHR would require government oversight. He said that the digital records systems, which store a patient’s medical history, don’t fit neatly under the agency’s existing mandate to regulate items such as drugs and medical devices.
Dr. Gottlieb said the best approach might be to say that an EHR that has a certain capability becomes a medical device. He called EHRs a “unique tool,” noting that the risks posed by their use aren’t the same as for a traditional medical device implanted in a patient. “You need a much different regulatory scheme,” he said.
The 21st Century Cures Act of 2016 excludes the FDA from having oversight over EHRs as a medical device.
Dr. Gottlieb said that health IT companies could add new functions that would improve EHRs, but they have been reluctant to do so because they didn’t want their products to fall under FDA jurisdiction. He added that he was “not calling” for FDA to take over such a duty, however, and suggested that any new approach could be years away. Proponents have long argued that widespread use of EHRs can make medicine safer by alerting doctors to potential medical errors, though critics counter that software glitches and user errors may cause new varieties of medical mistakes.
How closely the FDA should watch over the digital medical record revolution has been controversial for years. The agency’s interest in the issue perked up after Congress decided in February 2009 to spend billions of dollars on digital medical records as part of an economic stimulus program.
At the time, many industry groups argued that FDA regulation would “stifle innovation” and stall the national drive to bring medicine into the modern era. Federal officials responsible for doling out billions in subsidies to doctors and hospitals generally sympathized with that view and were skeptical of allowing the FDA to play a role.
The debate became public in February 2010, when Jeffrey Shuren, MD, an FDA official, testified at a public hearing that the agency had tied 6 deaths and more than 200 injuries to health information technology. In all, the FDA said, it had logged 260 reports in the previous 2 years of “malfunctions with the potential for patient harm.”
The agency said the findings were based largely on reports voluntarily submitted to the FDA and suggested “significant clinical implications and public safety issues.” In one case cited, lab tests done in a hospital emergency department were sent to the wrong patient’s file. Since then, several government and private repositories have associated thousands of injuries, near misses, and deaths to EHR technology.
Dr. Shuren said in 2010 that the agency recognized that health information technology had great potential to improve patient care, but also needed oversight to “assure patient safety.”
While some safety proponents agree that EHRs offer tremendous benefits, they also see a greater opportunities to improve their safety.
Dean Sittig, PhD, a professor of bioinformatics and bioengineering at the University of Texas, Houston, said EHRs have improved safety within the health care system, but they have not eliminated errors to the extent that he would have expected. Federal officials were initially pushing for rapid adoption and ‘there wasn’t a lot of interest in talking about things that could go wrong,’ ” Dr. Sittig told KHN and Fortune.
Earlier in March, Gottlieb announced his resignation from the FDA. His last day is scheduled to be April 5.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN correspondents Sarah Jane Tribble, Sydney Lupkin, and Julie Rovner contributed to this report.
“What we really need is a much more tailored approach, so that we have appropriate oversight of EHRs when they’re doing things that could create risk for patients,” Dr. Gottlieb said in an interview with Kaiser Health News.
Dr. Gottlieb was responding to “Botched Operation,” a report published March 18 by KHN and Fortune magazine. The investigation found that the federal government has spent more than $36 billion over the past 10 years to switch doctors and hospitals from paper to digital records systems. In that time, thousands of reports of deaths, injuries, and near misses linked to EHRs have piled up in databases – including at least one run by the FDA.
Dr. Gottlieb said Congress would need to enact legislation to define when an EHR would require government oversight. He said that the digital records systems, which store a patient’s medical history, don’t fit neatly under the agency’s existing mandate to regulate items such as drugs and medical devices.
Dr. Gottlieb said the best approach might be to say that an EHR that has a certain capability becomes a medical device. He called EHRs a “unique tool,” noting that the risks posed by their use aren’t the same as for a traditional medical device implanted in a patient. “You need a much different regulatory scheme,” he said.
The 21st Century Cures Act of 2016 excludes the FDA from having oversight over EHRs as a medical device.
Dr. Gottlieb said that health IT companies could add new functions that would improve EHRs, but they have been reluctant to do so because they didn’t want their products to fall under FDA jurisdiction. He added that he was “not calling” for FDA to take over such a duty, however, and suggested that any new approach could be years away. Proponents have long argued that widespread use of EHRs can make medicine safer by alerting doctors to potential medical errors, though critics counter that software glitches and user errors may cause new varieties of medical mistakes.
How closely the FDA should watch over the digital medical record revolution has been controversial for years. The agency’s interest in the issue perked up after Congress decided in February 2009 to spend billions of dollars on digital medical records as part of an economic stimulus program.
At the time, many industry groups argued that FDA regulation would “stifle innovation” and stall the national drive to bring medicine into the modern era. Federal officials responsible for doling out billions in subsidies to doctors and hospitals generally sympathized with that view and were skeptical of allowing the FDA to play a role.
The debate became public in February 2010, when Jeffrey Shuren, MD, an FDA official, testified at a public hearing that the agency had tied 6 deaths and more than 200 injuries to health information technology. In all, the FDA said, it had logged 260 reports in the previous 2 years of “malfunctions with the potential for patient harm.”
The agency said the findings were based largely on reports voluntarily submitted to the FDA and suggested “significant clinical implications and public safety issues.” In one case cited, lab tests done in a hospital emergency department were sent to the wrong patient’s file. Since then, several government and private repositories have associated thousands of injuries, near misses, and deaths to EHR technology.
Dr. Shuren said in 2010 that the agency recognized that health information technology had great potential to improve patient care, but also needed oversight to “assure patient safety.”
While some safety proponents agree that EHRs offer tremendous benefits, they also see a greater opportunities to improve their safety.
Dean Sittig, PhD, a professor of bioinformatics and bioengineering at the University of Texas, Houston, said EHRs have improved safety within the health care system, but they have not eliminated errors to the extent that he would have expected. Federal officials were initially pushing for rapid adoption and ‘there wasn’t a lot of interest in talking about things that could go wrong,’ ” Dr. Sittig told KHN and Fortune.
Earlier in March, Gottlieb announced his resignation from the FDA. His last day is scheduled to be April 5.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN correspondents Sarah Jane Tribble, Sydney Lupkin, and Julie Rovner contributed to this report.
“What we really need is a much more tailored approach, so that we have appropriate oversight of EHRs when they’re doing things that could create risk for patients,” Dr. Gottlieb said in an interview with Kaiser Health News.
Dr. Gottlieb was responding to “Botched Operation,” a report published March 18 by KHN and Fortune magazine. The investigation found that the federal government has spent more than $36 billion over the past 10 years to switch doctors and hospitals from paper to digital records systems. In that time, thousands of reports of deaths, injuries, and near misses linked to EHRs have piled up in databases – including at least one run by the FDA.
Dr. Gottlieb said Congress would need to enact legislation to define when an EHR would require government oversight. He said that the digital records systems, which store a patient’s medical history, don’t fit neatly under the agency’s existing mandate to regulate items such as drugs and medical devices.
Dr. Gottlieb said the best approach might be to say that an EHR that has a certain capability becomes a medical device. He called EHRs a “unique tool,” noting that the risks posed by their use aren’t the same as for a traditional medical device implanted in a patient. “You need a much different regulatory scheme,” he said.
The 21st Century Cures Act of 2016 excludes the FDA from having oversight over EHRs as a medical device.
Dr. Gottlieb said that health IT companies could add new functions that would improve EHRs, but they have been reluctant to do so because they didn’t want their products to fall under FDA jurisdiction. He added that he was “not calling” for FDA to take over such a duty, however, and suggested that any new approach could be years away. Proponents have long argued that widespread use of EHRs can make medicine safer by alerting doctors to potential medical errors, though critics counter that software glitches and user errors may cause new varieties of medical mistakes.
How closely the FDA should watch over the digital medical record revolution has been controversial for years. The agency’s interest in the issue perked up after Congress decided in February 2009 to spend billions of dollars on digital medical records as part of an economic stimulus program.
At the time, many industry groups argued that FDA regulation would “stifle innovation” and stall the national drive to bring medicine into the modern era. Federal officials responsible for doling out billions in subsidies to doctors and hospitals generally sympathized with that view and were skeptical of allowing the FDA to play a role.
The debate became public in February 2010, when Jeffrey Shuren, MD, an FDA official, testified at a public hearing that the agency had tied 6 deaths and more than 200 injuries to health information technology. In all, the FDA said, it had logged 260 reports in the previous 2 years of “malfunctions with the potential for patient harm.”
The agency said the findings were based largely on reports voluntarily submitted to the FDA and suggested “significant clinical implications and public safety issues.” In one case cited, lab tests done in a hospital emergency department were sent to the wrong patient’s file. Since then, several government and private repositories have associated thousands of injuries, near misses, and deaths to EHR technology.
Dr. Shuren said in 2010 that the agency recognized that health information technology had great potential to improve patient care, but also needed oversight to “assure patient safety.”
While some safety proponents agree that EHRs offer tremendous benefits, they also see a greater opportunities to improve their safety.
Dean Sittig, PhD, a professor of bioinformatics and bioengineering at the University of Texas, Houston, said EHRs have improved safety within the health care system, but they have not eliminated errors to the extent that he would have expected. Federal officials were initially pushing for rapid adoption and ‘there wasn’t a lot of interest in talking about things that could go wrong,’ ” Dr. Sittig told KHN and Fortune.
Earlier in March, Gottlieb announced his resignation from the FDA. His last day is scheduled to be April 5.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN correspondents Sarah Jane Tribble, Sydney Lupkin, and Julie Rovner contributed to this report.
Justice Department joins lawsuit alleging massive Medicare fraud by UnitedHealth
The Justice Department has joined a California whistle-blower’s lawsuit that accuses insurance giant UnitedHealth Group of fraud in its popular Medicare Advantage health plans.
Justice officials filed legal papers to intervene in the suit, first brought by whistle-blower James Swoben in 2009, on Friday in federal court in Los Angeles. On Monday, they sought a court order to combine Mr. Swoben’s case with that of another whistle-blower.
Mr. Swoben has accused the insurer of “gaming” the Medicare Advantage payment system by “making patients look sicker than they are,” said his attorney, William K. Hanagami. Mr. Hanagami said the combined cases could prove to be among the “larger frauds” ever against Medicare, with damages that he speculates could top $1 billion.
UnitedHealth spokesman Matt Burns denied any wrongdoing by the company. “We are honored to serve millions of seniors through Medicare Advantage, proud of the access to quality health care we provided, and confident we complied with program rules,” he wrote in an email.
Mr. Burns also said that “litigating against Medicare Advantage plans to create new rules through the courts will not fix widely acknowledged government policy shortcomings or help Medicare Advantage members and is wrong.”
Medicare Advantage is a popular alternative to traditional Medicare. The privately run health plans have enrolled more than 18 million elderly and people with disabilities – about a third of those eligible for Medicare – at a cost to taxpayers of more than $150 billion a year.
Although the plans generally enjoy strong support in Congress, they have been the target of at least a half-dozen whistle-blower lawsuits alleging patterns of overbilling and fraud. In most of the prior cases, Justice Department officials have decided not to intervene, which often limits the financial recovery by the government and also by whistle-blowers, who can be awarded a portion of recovered funds. A decision to intervene means that the Justice Department is taking over the investigation of the case, greatly raising the stakes.
“This is a very big development and sends a strong signal that the Trump administration is very serious when it comes to fighting fraud in the health care arena,” said Patrick Burns, associate director of Taxpayers Against Fraud in Washington, a nonprofit supported by whistle-blowers and their lawyers. Burns said the “winners here are going to be American taxpayers.”
Patrick Burns also contends that the cases against UnitedHealth could potentially exceed $1 billion in damages, which would place them among the top two or three whistle-blower–prompted cases on record.
“This is not one company engaged in episodic bad behavior, but a lucrative business plan that appears to be national in scope,” he said.
On Monday, the government said it wants to consolidate the Swoben case with another whistle-blower action filed in 2011 by former UnitedHealth executive Benjamin Poehling and unsealed in March by a federal judge. Mr. Poehling also has alleged that the insurer generated hundreds of millions of dollars or more in overpayments.
When Congress created the current Medicare Advantage program in 2003, it expected to pay higher rates for sicker patients than for people in good health using a formula called a risk score.
But, overspending tied to inflated risk scores has repeatedly been cited by government auditors, including the Government Accountability Office. A series of articles published in 2014 by the Center for Public Integrity found that these improper payments have cost taxpayers tens of billions of dollars.
“If the goal of fraud is to artificially increase risk scores and you do that wholesale, that results in some rather significant dollars,” Mr. Hanagami said.
David Lipschutz, senior policy attorney for the Center for Medicare Advocacy, a nonprofit offering legal assistance and other resources for those eligible for Medicare, said his group is “deeply concerned by ongoing improper payments” to Medicare Advantage health plans.
These overpayments “undermine the finances of the overall Medicare program,” he said in an emailed statement. He said his group supports “more rigorous oversight” of payments made to the health plans.
The two whistle-blower complaints allege that UnitedHealth has had a practice of asking the government to reimburse it for underpayments but did not report claims for which it had received too much money, despite knowing some of these claims had inflated risk scores.
The federal Centers for Medicare & Medicaid Services said in draft regulations issued in January 2014 that it would begin requiring that Medicare Advantage plans report any improper payment – either too much or too little.
These reviews “cannot be designed only to identify diagnoses that would trigger additional payments,” the proposal stated.
But CMS backed off the regulation’s reporting requirements in the face of opposition from the insurance industry. The agency didn’t say why it did so.
The Justice Department said in an April 2016 amicus brief in the Swoben case that the CMS decision not to move ahead with the reporting regulation “does not relieve defendants of the broad obligation to exercise due diligence in ensuring the accuracy” of claims submitted for payment.
The Justice Department concluded in the brief that the insurers “chose not to connect the dots,” even though they knew of both overpayments and underpayments. Instead, the insurers “acted in a deliberately ignorant or reckless manner in falsely certifying the accuracy, completeness, and truthfulness of submitted data,” the 2016 brief states.
The Justice Department has said it also is investigating risk-score payments to other Medicare Advantage insurers, but has not said whether it plans to take action against any of them.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
The Justice Department has joined a California whistle-blower’s lawsuit that accuses insurance giant UnitedHealth Group of fraud in its popular Medicare Advantage health plans.
Justice officials filed legal papers to intervene in the suit, first brought by whistle-blower James Swoben in 2009, on Friday in federal court in Los Angeles. On Monday, they sought a court order to combine Mr. Swoben’s case with that of another whistle-blower.
Mr. Swoben has accused the insurer of “gaming” the Medicare Advantage payment system by “making patients look sicker than they are,” said his attorney, William K. Hanagami. Mr. Hanagami said the combined cases could prove to be among the “larger frauds” ever against Medicare, with damages that he speculates could top $1 billion.
UnitedHealth spokesman Matt Burns denied any wrongdoing by the company. “We are honored to serve millions of seniors through Medicare Advantage, proud of the access to quality health care we provided, and confident we complied with program rules,” he wrote in an email.
Mr. Burns also said that “litigating against Medicare Advantage plans to create new rules through the courts will not fix widely acknowledged government policy shortcomings or help Medicare Advantage members and is wrong.”
Medicare Advantage is a popular alternative to traditional Medicare. The privately run health plans have enrolled more than 18 million elderly and people with disabilities – about a third of those eligible for Medicare – at a cost to taxpayers of more than $150 billion a year.
Although the plans generally enjoy strong support in Congress, they have been the target of at least a half-dozen whistle-blower lawsuits alleging patterns of overbilling and fraud. In most of the prior cases, Justice Department officials have decided not to intervene, which often limits the financial recovery by the government and also by whistle-blowers, who can be awarded a portion of recovered funds. A decision to intervene means that the Justice Department is taking over the investigation of the case, greatly raising the stakes.
“This is a very big development and sends a strong signal that the Trump administration is very serious when it comes to fighting fraud in the health care arena,” said Patrick Burns, associate director of Taxpayers Against Fraud in Washington, a nonprofit supported by whistle-blowers and their lawyers. Burns said the “winners here are going to be American taxpayers.”
Patrick Burns also contends that the cases against UnitedHealth could potentially exceed $1 billion in damages, which would place them among the top two or three whistle-blower–prompted cases on record.
“This is not one company engaged in episodic bad behavior, but a lucrative business plan that appears to be national in scope,” he said.
On Monday, the government said it wants to consolidate the Swoben case with another whistle-blower action filed in 2011 by former UnitedHealth executive Benjamin Poehling and unsealed in March by a federal judge. Mr. Poehling also has alleged that the insurer generated hundreds of millions of dollars or more in overpayments.
When Congress created the current Medicare Advantage program in 2003, it expected to pay higher rates for sicker patients than for people in good health using a formula called a risk score.
But, overspending tied to inflated risk scores has repeatedly been cited by government auditors, including the Government Accountability Office. A series of articles published in 2014 by the Center for Public Integrity found that these improper payments have cost taxpayers tens of billions of dollars.
“If the goal of fraud is to artificially increase risk scores and you do that wholesale, that results in some rather significant dollars,” Mr. Hanagami said.
David Lipschutz, senior policy attorney for the Center for Medicare Advocacy, a nonprofit offering legal assistance and other resources for those eligible for Medicare, said his group is “deeply concerned by ongoing improper payments” to Medicare Advantage health plans.
These overpayments “undermine the finances of the overall Medicare program,” he said in an emailed statement. He said his group supports “more rigorous oversight” of payments made to the health plans.
The two whistle-blower complaints allege that UnitedHealth has had a practice of asking the government to reimburse it for underpayments but did not report claims for which it had received too much money, despite knowing some of these claims had inflated risk scores.
The federal Centers for Medicare & Medicaid Services said in draft regulations issued in January 2014 that it would begin requiring that Medicare Advantage plans report any improper payment – either too much or too little.
These reviews “cannot be designed only to identify diagnoses that would trigger additional payments,” the proposal stated.
But CMS backed off the regulation’s reporting requirements in the face of opposition from the insurance industry. The agency didn’t say why it did so.
The Justice Department said in an April 2016 amicus brief in the Swoben case that the CMS decision not to move ahead with the reporting regulation “does not relieve defendants of the broad obligation to exercise due diligence in ensuring the accuracy” of claims submitted for payment.
The Justice Department concluded in the brief that the insurers “chose not to connect the dots,” even though they knew of both overpayments and underpayments. Instead, the insurers “acted in a deliberately ignorant or reckless manner in falsely certifying the accuracy, completeness, and truthfulness of submitted data,” the 2016 brief states.
The Justice Department has said it also is investigating risk-score payments to other Medicare Advantage insurers, but has not said whether it plans to take action against any of them.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
The Justice Department has joined a California whistle-blower’s lawsuit that accuses insurance giant UnitedHealth Group of fraud in its popular Medicare Advantage health plans.
Justice officials filed legal papers to intervene in the suit, first brought by whistle-blower James Swoben in 2009, on Friday in federal court in Los Angeles. On Monday, they sought a court order to combine Mr. Swoben’s case with that of another whistle-blower.
Mr. Swoben has accused the insurer of “gaming” the Medicare Advantage payment system by “making patients look sicker than they are,” said his attorney, William K. Hanagami. Mr. Hanagami said the combined cases could prove to be among the “larger frauds” ever against Medicare, with damages that he speculates could top $1 billion.
UnitedHealth spokesman Matt Burns denied any wrongdoing by the company. “We are honored to serve millions of seniors through Medicare Advantage, proud of the access to quality health care we provided, and confident we complied with program rules,” he wrote in an email.
Mr. Burns also said that “litigating against Medicare Advantage plans to create new rules through the courts will not fix widely acknowledged government policy shortcomings or help Medicare Advantage members and is wrong.”
Medicare Advantage is a popular alternative to traditional Medicare. The privately run health plans have enrolled more than 18 million elderly and people with disabilities – about a third of those eligible for Medicare – at a cost to taxpayers of more than $150 billion a year.
Although the plans generally enjoy strong support in Congress, they have been the target of at least a half-dozen whistle-blower lawsuits alleging patterns of overbilling and fraud. In most of the prior cases, Justice Department officials have decided not to intervene, which often limits the financial recovery by the government and also by whistle-blowers, who can be awarded a portion of recovered funds. A decision to intervene means that the Justice Department is taking over the investigation of the case, greatly raising the stakes.
“This is a very big development and sends a strong signal that the Trump administration is very serious when it comes to fighting fraud in the health care arena,” said Patrick Burns, associate director of Taxpayers Against Fraud in Washington, a nonprofit supported by whistle-blowers and their lawyers. Burns said the “winners here are going to be American taxpayers.”
Patrick Burns also contends that the cases against UnitedHealth could potentially exceed $1 billion in damages, which would place them among the top two or three whistle-blower–prompted cases on record.
“This is not one company engaged in episodic bad behavior, but a lucrative business plan that appears to be national in scope,” he said.
On Monday, the government said it wants to consolidate the Swoben case with another whistle-blower action filed in 2011 by former UnitedHealth executive Benjamin Poehling and unsealed in March by a federal judge. Mr. Poehling also has alleged that the insurer generated hundreds of millions of dollars or more in overpayments.
When Congress created the current Medicare Advantage program in 2003, it expected to pay higher rates for sicker patients than for people in good health using a formula called a risk score.
But, overspending tied to inflated risk scores has repeatedly been cited by government auditors, including the Government Accountability Office. A series of articles published in 2014 by the Center for Public Integrity found that these improper payments have cost taxpayers tens of billions of dollars.
“If the goal of fraud is to artificially increase risk scores and you do that wholesale, that results in some rather significant dollars,” Mr. Hanagami said.
David Lipschutz, senior policy attorney for the Center for Medicare Advocacy, a nonprofit offering legal assistance and other resources for those eligible for Medicare, said his group is “deeply concerned by ongoing improper payments” to Medicare Advantage health plans.
These overpayments “undermine the finances of the overall Medicare program,” he said in an emailed statement. He said his group supports “more rigorous oversight” of payments made to the health plans.
The two whistle-blower complaints allege that UnitedHealth has had a practice of asking the government to reimburse it for underpayments but did not report claims for which it had received too much money, despite knowing some of these claims had inflated risk scores.
The federal Centers for Medicare & Medicaid Services said in draft regulations issued in January 2014 that it would begin requiring that Medicare Advantage plans report any improper payment – either too much or too little.
These reviews “cannot be designed only to identify diagnoses that would trigger additional payments,” the proposal stated.
But CMS backed off the regulation’s reporting requirements in the face of opposition from the insurance industry. The agency didn’t say why it did so.
The Justice Department said in an April 2016 amicus brief in the Swoben case that the CMS decision not to move ahead with the reporting regulation “does not relieve defendants of the broad obligation to exercise due diligence in ensuring the accuracy” of claims submitted for payment.
The Justice Department concluded in the brief that the insurers “chose not to connect the dots,” even though they knew of both overpayments and underpayments. Instead, the insurers “acted in a deliberately ignorant or reckless manner in falsely certifying the accuracy, completeness, and truthfulness of submitted data,” the 2016 brief states.
The Justice Department has said it also is investigating risk-score payments to other Medicare Advantage insurers, but has not said whether it plans to take action against any of them.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.