User login
Lose weight, gain huge debt: N.Y. provider has sued more than 300 patients who had bariatric surgery
Seven months after Lahavah Wallace’s weight-loss operation, a New York bariatric surgery practice sued her, accusing her of “intentionally” failing to pay nearly $18,000 of her bill.
Long Island Minimally Invasive Surgery, which does business as the New York Bariatric Group, went on to accuse Ms. Wallace of “embezzlement,” alleging she kept insurance payments that should have been turned over to the practice.
Ms. Wallace denies the allegations, which the bariatric practice has leveled against patients in hundreds of debt-collection lawsuits filed over the past 4 years, court records in New York state show.
In about 60 cases, the lawsuits demanded $100,000 or more from patients. Some patients were found liable for tens of thousands of dollars in interest charges or wound up shackled with debt that could take a decade or more to shake. Others are facing the likely prospect of six-figure financial penalties, court records show.
Backed by a major private equity firm, the bariatric practice spends millions each year on advertisements featuring patients who have dropped 100 pounds or more after bariatric procedures, sometimes having had a portion of their stomachs removed. The ads have run on TV, online, and on New York City subway posters.
The online ads, often showcasing the slogan “Stop obesity for life,” appealed to Ms. Wallace, who lives in Brooklyn and works as a legal assistant for the state of New York. She said she turned over checks from her insurer to the bariatric group and was stunned when the medical practice hauled her into court citing an “out-of-network payment agreement” she had signed before her surgery.
“I really didn’t know what I was signing,” Ms. Wallace told KFF Health News. “I didn’t pay enough attention.”
Shawn Garber, MD, a bariatric surgeon who founded the practice in 2000 on Long Island and serves as its CEO, said that “prior to rendering services” his office staff advises patients of the costs and their responsibility to pay the bill.
The bariatric group has cited these out-of-network payment agreements in at least 300 lawsuits filed against patients from January 2019 to 2022 demanding nearly $19 million to cover medical bills, interest charges, and attorney’s fees, a KFF Health News review of New York state court records found.
Danny De Voe, a partner at Sahn Ward Braff Koblenz law firm in Uniondale, N.Y., who filed many of those suits, declined to comment, citing attorney-client privilege.
In most cases, the medical practice had agreed to accept an insurance company’s out-of-network rate as full payment for its services – with caveats, according to court filings.
In the agreements they signed, patients promised to pay any coinsurance, meeting any deductible, and pass on to the medical practice any reimbursement checks they received from their health plans within 7 days.
KFF Health News found – while legal fees and other costs can layer on thousands more.
Elisabeth Benjamin, a lawyer with the Community Service Society of New York, said conflicts can arise when insurers send checks to pay for out-of-network medical services to patients rather than reimbursing a medical provider directly.
“We would prefer to see regulators step in and stop that practice,” she said, adding it “causes tension between providers and patients.”
That’s certainly true for Ms. Wallace. The surgery practice sued her in August 2022demanding $17,981 in fees it said remained unpaid after her January 2022 laparoscopic sleeve gastrectomy, an operation in which much of the stomach is removed to assist weight loss.
The lawsuit also tacked on a demand for $5,993 in attorney’s fees, court records show.
The suit alleges Ms. Wallace signed the contract even though she “had no intention” of paying her bills. The complaint goes on to accuse her of “committing embezzlement” by “willfully, intentionally, deliberately and maliciously” depositing checks from her health plan into her personal account.
The suit doesn’t include details to substantiate these claims, and Ms. Wallace said in her court response they are not true. Ms. Wallace said she turned over checks for the charges.
“They billed the insurance for everything they possibly could,” Ms. Wallace said.
In September, Ms. Wallace filed for bankruptcy, hoping to discharge the bariatric care debt along with about $4,700 in unrelated credit card charges.
The medical practice fired back in November by filing an “adversary complaint” in her Brooklyn bankruptcy court proceeding that argues her medical debt should not be forgiven because Ms. Wallace committed fraud.
The adversary complaint, which is pending in the bankruptcy case, accuses Ms. Wallace of “fraudulently” inducing the surgery center to perform “elective medical procedures” without requiring payment up front.
Both the harsh wording and claims of wrongdoing have infuriated Ms. Wallace and her attorney, Jacob Silver, of Brooklyn.
Mr. Silver wants the medical practice to turn over records of the payments received from Ms. Wallace. “There is no fraud here,” he said. “This is frivolous. We are taking a no-settlement position.”
Gaining debt
Few patients sued by the bariatric practice mount a defense in court and those who do fight often lose, court records show.
The medical practice won default judgments totaling nearly $6 million in about 90 of the 300 cases in the sample reviewed by KFF Health News. Default judgments are entered when the defendant fails to respond.
Many cases either are pending, or it is not clear from court filings how they were resolved.
Some patients tried to argue that the fees were too high or that they didn’t understand going in how much they could owe. One woman, trying to push back against a demand for more than $100,000, said in a legal filing that she “was given numerous papers to sign without anyone of the staff members explaining to me what it actually meant.” Another patient, who was sued for more than $40,000, wrote: “I don’t have the means to pay this bill.”
Among the cases described in court records:
- A Westchester County, N.Y., woman was sued for $102,556 and settled for $72,000 in May 2021. She agreed to pay $7,500 upon signing the settlement and $500 a month from September 2021 to May 2032.
- A Peekskill, N.Y., woman in a December 2019 judgment was held liable for $384,092, which included $94,047 in interest.
- A Newburgh, N.Y., man was sued in 2021 for $252,309 in medical bills, 12% interest, and $84,103 in attorneys’ fees. The case is pending.
Robert Cohen, a longtime attorney for the bariatric practice, testified in a November 2021 hearing that the lawyers take “a contingency fee of one-third of our recovery” in these cases. In that case, Mr. Cohen had requested $13,578 based on his contingency fee arrangement. He testified that he spent 7.3 hours on the case and that his customary billing rate was $475 per hour, which came to $3,467.50. The judge awarded the lower amount, according to a transcript of the hearing.
Teresa LaMasters, MD, president of the American Society for Metabolic and Bariatric Surgery, said suing patients for large sums “is not a common practice” among bariatric surgeons.
“This is not what the vast majority in the field would espouse,” she said.
But Dr. Garber, the NYBG’s chief executive, suggested patients deserve blame.
“These lawsuits stem from these patients stealing the insurance money rather than forwarding it onto NYBG as they are morally and contractually obligated to do,” Dr. Garber wrote in an email to KFF Health News.
Dr. Garber added: “The issue is not with what we bill, but rather with the fact that the insurance companies refuse to send payment directly to us.”
‘A kooky system’
Defense attorneys argue that many patients don’t fully comprehend the perils of failing to pay on time – for whatever reason.
In a few cases, patients admitted pocketing checks they were obligated to turn over to the medical practice. But for the most part, court records don’t specify how many such checks were issued and for what amounts – or whether the patient improperly cashed them.
“It’s a kooky system,” said Paul Brite, an attorney who has faced off against the bariatric practice in court.
“You sign these documents that could cost you tons of money. It shouldn’t be that way,” he said. “This can ruin their financial life.”
New York lawmakers have acted to limit the damage from medical debt, including “surprise bills.”
In November, Democratic Gov. Kathy Hochul signed legislation that prohibits health care providers from slapping liens on a primary residence or garnishing wages.
But contracts with onerous repayment terms represent an “evolving area of law” and an alarming “new twist” on concerns over medical debt, said Ms. Benjamin, the community service society lawyer.
She said contract “accelerator clauses” that trigger severe penalties if patients miss payments should not be permitted for medical debt.
“If you default, the full amount is due,” she said. “This is really a bummer.”
‘Fair market value’
The debt collection lawsuits argue that weight-loss patients had agreed to pay “fair market value” for services – and the doctors are only trying to secure money they are due.
But some prices far exceed typical insurance payments for obesity treatments across the country, according to a medical billing data registry. Surgeons performed about 200,000 bariatric operations in 2020, according to the bariatric surgery society.
Ms. Wallace, the Brooklyn legal assistant, was billed $60,500 for her lap sleeve gastrectomy, though how much her insurance actually paid remains to be hashed out in court.
Michael Arrigo, a California medical billing expert at No World Borders, called the prices “outrageous” and “unreasonable and, in fact, likely unconscionable.”
“I disagree that these are fair market charges,” he said.
Dr. LaMasters called the gastrectomy price billed to Ms. Wallace “really expensive” and “a severe outlier.” While charges vary by region, she quoted a typical price of around $22,000.
Dr. Garber said NYBG “bills at usual and customary rates” determined by Fair Health, a New York City-based repository of insurance claims data. Fair Health “sets these rates based upon the acceptable price for our geographic location,” he said.
But Rachel Kent, Fair Health’s senior director of marketing, told KFF Health News that the group “does not set rates, nor determine or take any position on what constitutes ‘usual and customary rates.’ ” Instead, it reports the prices providers are charging in a given area.
Overall, Fair Health data shows huge price variations even in adjacent ZIP codes in the metro area. In Long Island’s Roslyn Heights neighborhood, where NYBG is based, Fair Health lists the out-of-network price charged by providers in the area as $60,500, the figure Ms. Wallace was billed.
But in several other New York City–area ZIP codes the price charged for the gastrectomy procedure hovers around $20,000, according to the data bank. The price in Manhattan is $17,500, for instance, according to Fair Health.
Nationwide, the average cost in 2021 for bariatric surgery done in a hospital was $32,868, according to a KFF analysis of health insurance claims.
Private equity arrives
Dr. Garber said in a court affidavit in May 2022 that he founded the bariatric practice “with a singular focus: providing safe, effective care to patients suffering from obesity and its resulting complications.”
Under his leadership, the practice has “developed into New York’s elite institution for obesity treatment,” Dr. Garber said. He said the group’s surgeons are “highly sought after to train other bariatric surgeons throughout the country and are active in the development of new, cutting-edge bariatric surgery techniques.”
In 2017, Dr. Garber and partners agreed on a business plan to help spur growth and “attract private equity investment,” according to the affidavit.
They formed a separate company to handle the bariatric practice’s business side. Known as management services organizations, such companies provide a way for private equity investors to circumvent laws in some states that prohibit nonphysicians from owning a stake in a medical practice.
In August 2019, the private equity firm Sentinel Capital Partners bought 65% of the MSO for $156.5 million, according to Dr. Garber’s affidavit. The management company is now known as New You Bariatric Group. The private equity firm did not respond to requests for comment.
Dr. Garber, in a September 2021 American Society for Metabolic and Bariatric Surgery webinar viewable online, said the weight-loss practice spends $6 million a year on media and marketing directly to patients – and is on a roll. Nationally, bariatric surgery is growing 6% annually, he said. NYBG boasts two dozen offices in the tri-state area of New York, New Jersey, and Connecticut and is poised to expand into more states.
“Since private equity, we’ve been growing at 30%-40% year over year,” Dr. Garber said.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Seven months after Lahavah Wallace’s weight-loss operation, a New York bariatric surgery practice sued her, accusing her of “intentionally” failing to pay nearly $18,000 of her bill.
Long Island Minimally Invasive Surgery, which does business as the New York Bariatric Group, went on to accuse Ms. Wallace of “embezzlement,” alleging she kept insurance payments that should have been turned over to the practice.
Ms. Wallace denies the allegations, which the bariatric practice has leveled against patients in hundreds of debt-collection lawsuits filed over the past 4 years, court records in New York state show.
In about 60 cases, the lawsuits demanded $100,000 or more from patients. Some patients were found liable for tens of thousands of dollars in interest charges or wound up shackled with debt that could take a decade or more to shake. Others are facing the likely prospect of six-figure financial penalties, court records show.
Backed by a major private equity firm, the bariatric practice spends millions each year on advertisements featuring patients who have dropped 100 pounds or more after bariatric procedures, sometimes having had a portion of their stomachs removed. The ads have run on TV, online, and on New York City subway posters.
The online ads, often showcasing the slogan “Stop obesity for life,” appealed to Ms. Wallace, who lives in Brooklyn and works as a legal assistant for the state of New York. She said she turned over checks from her insurer to the bariatric group and was stunned when the medical practice hauled her into court citing an “out-of-network payment agreement” she had signed before her surgery.
“I really didn’t know what I was signing,” Ms. Wallace told KFF Health News. “I didn’t pay enough attention.”
Shawn Garber, MD, a bariatric surgeon who founded the practice in 2000 on Long Island and serves as its CEO, said that “prior to rendering services” his office staff advises patients of the costs and their responsibility to pay the bill.
The bariatric group has cited these out-of-network payment agreements in at least 300 lawsuits filed against patients from January 2019 to 2022 demanding nearly $19 million to cover medical bills, interest charges, and attorney’s fees, a KFF Health News review of New York state court records found.
Danny De Voe, a partner at Sahn Ward Braff Koblenz law firm in Uniondale, N.Y., who filed many of those suits, declined to comment, citing attorney-client privilege.
In most cases, the medical practice had agreed to accept an insurance company’s out-of-network rate as full payment for its services – with caveats, according to court filings.
In the agreements they signed, patients promised to pay any coinsurance, meeting any deductible, and pass on to the medical practice any reimbursement checks they received from their health plans within 7 days.
KFF Health News found – while legal fees and other costs can layer on thousands more.
Elisabeth Benjamin, a lawyer with the Community Service Society of New York, said conflicts can arise when insurers send checks to pay for out-of-network medical services to patients rather than reimbursing a medical provider directly.
“We would prefer to see regulators step in and stop that practice,” she said, adding it “causes tension between providers and patients.”
That’s certainly true for Ms. Wallace. The surgery practice sued her in August 2022demanding $17,981 in fees it said remained unpaid after her January 2022 laparoscopic sleeve gastrectomy, an operation in which much of the stomach is removed to assist weight loss.
The lawsuit also tacked on a demand for $5,993 in attorney’s fees, court records show.
The suit alleges Ms. Wallace signed the contract even though she “had no intention” of paying her bills. The complaint goes on to accuse her of “committing embezzlement” by “willfully, intentionally, deliberately and maliciously” depositing checks from her health plan into her personal account.
The suit doesn’t include details to substantiate these claims, and Ms. Wallace said in her court response they are not true. Ms. Wallace said she turned over checks for the charges.
“They billed the insurance for everything they possibly could,” Ms. Wallace said.
In September, Ms. Wallace filed for bankruptcy, hoping to discharge the bariatric care debt along with about $4,700 in unrelated credit card charges.
The medical practice fired back in November by filing an “adversary complaint” in her Brooklyn bankruptcy court proceeding that argues her medical debt should not be forgiven because Ms. Wallace committed fraud.
The adversary complaint, which is pending in the bankruptcy case, accuses Ms. Wallace of “fraudulently” inducing the surgery center to perform “elective medical procedures” without requiring payment up front.
Both the harsh wording and claims of wrongdoing have infuriated Ms. Wallace and her attorney, Jacob Silver, of Brooklyn.
Mr. Silver wants the medical practice to turn over records of the payments received from Ms. Wallace. “There is no fraud here,” he said. “This is frivolous. We are taking a no-settlement position.”
Gaining debt
Few patients sued by the bariatric practice mount a defense in court and those who do fight often lose, court records show.
The medical practice won default judgments totaling nearly $6 million in about 90 of the 300 cases in the sample reviewed by KFF Health News. Default judgments are entered when the defendant fails to respond.
Many cases either are pending, or it is not clear from court filings how they were resolved.
Some patients tried to argue that the fees were too high or that they didn’t understand going in how much they could owe. One woman, trying to push back against a demand for more than $100,000, said in a legal filing that she “was given numerous papers to sign without anyone of the staff members explaining to me what it actually meant.” Another patient, who was sued for more than $40,000, wrote: “I don’t have the means to pay this bill.”
Among the cases described in court records:
- A Westchester County, N.Y., woman was sued for $102,556 and settled for $72,000 in May 2021. She agreed to pay $7,500 upon signing the settlement and $500 a month from September 2021 to May 2032.
- A Peekskill, N.Y., woman in a December 2019 judgment was held liable for $384,092, which included $94,047 in interest.
- A Newburgh, N.Y., man was sued in 2021 for $252,309 in medical bills, 12% interest, and $84,103 in attorneys’ fees. The case is pending.
Robert Cohen, a longtime attorney for the bariatric practice, testified in a November 2021 hearing that the lawyers take “a contingency fee of one-third of our recovery” in these cases. In that case, Mr. Cohen had requested $13,578 based on his contingency fee arrangement. He testified that he spent 7.3 hours on the case and that his customary billing rate was $475 per hour, which came to $3,467.50. The judge awarded the lower amount, according to a transcript of the hearing.
Teresa LaMasters, MD, president of the American Society for Metabolic and Bariatric Surgery, said suing patients for large sums “is not a common practice” among bariatric surgeons.
“This is not what the vast majority in the field would espouse,” she said.
But Dr. Garber, the NYBG’s chief executive, suggested patients deserve blame.
“These lawsuits stem from these patients stealing the insurance money rather than forwarding it onto NYBG as they are morally and contractually obligated to do,” Dr. Garber wrote in an email to KFF Health News.
Dr. Garber added: “The issue is not with what we bill, but rather with the fact that the insurance companies refuse to send payment directly to us.”
‘A kooky system’
Defense attorneys argue that many patients don’t fully comprehend the perils of failing to pay on time – for whatever reason.
In a few cases, patients admitted pocketing checks they were obligated to turn over to the medical practice. But for the most part, court records don’t specify how many such checks were issued and for what amounts – or whether the patient improperly cashed them.
“It’s a kooky system,” said Paul Brite, an attorney who has faced off against the bariatric practice in court.
“You sign these documents that could cost you tons of money. It shouldn’t be that way,” he said. “This can ruin their financial life.”
New York lawmakers have acted to limit the damage from medical debt, including “surprise bills.”
In November, Democratic Gov. Kathy Hochul signed legislation that prohibits health care providers from slapping liens on a primary residence or garnishing wages.
But contracts with onerous repayment terms represent an “evolving area of law” and an alarming “new twist” on concerns over medical debt, said Ms. Benjamin, the community service society lawyer.
She said contract “accelerator clauses” that trigger severe penalties if patients miss payments should not be permitted for medical debt.
“If you default, the full amount is due,” she said. “This is really a bummer.”
‘Fair market value’
The debt collection lawsuits argue that weight-loss patients had agreed to pay “fair market value” for services – and the doctors are only trying to secure money they are due.
But some prices far exceed typical insurance payments for obesity treatments across the country, according to a medical billing data registry. Surgeons performed about 200,000 bariatric operations in 2020, according to the bariatric surgery society.
Ms. Wallace, the Brooklyn legal assistant, was billed $60,500 for her lap sleeve gastrectomy, though how much her insurance actually paid remains to be hashed out in court.
Michael Arrigo, a California medical billing expert at No World Borders, called the prices “outrageous” and “unreasonable and, in fact, likely unconscionable.”
“I disagree that these are fair market charges,” he said.
Dr. LaMasters called the gastrectomy price billed to Ms. Wallace “really expensive” and “a severe outlier.” While charges vary by region, she quoted a typical price of around $22,000.
Dr. Garber said NYBG “bills at usual and customary rates” determined by Fair Health, a New York City-based repository of insurance claims data. Fair Health “sets these rates based upon the acceptable price for our geographic location,” he said.
But Rachel Kent, Fair Health’s senior director of marketing, told KFF Health News that the group “does not set rates, nor determine or take any position on what constitutes ‘usual and customary rates.’ ” Instead, it reports the prices providers are charging in a given area.
Overall, Fair Health data shows huge price variations even in adjacent ZIP codes in the metro area. In Long Island’s Roslyn Heights neighborhood, where NYBG is based, Fair Health lists the out-of-network price charged by providers in the area as $60,500, the figure Ms. Wallace was billed.
But in several other New York City–area ZIP codes the price charged for the gastrectomy procedure hovers around $20,000, according to the data bank. The price in Manhattan is $17,500, for instance, according to Fair Health.
Nationwide, the average cost in 2021 for bariatric surgery done in a hospital was $32,868, according to a KFF analysis of health insurance claims.
Private equity arrives
Dr. Garber said in a court affidavit in May 2022 that he founded the bariatric practice “with a singular focus: providing safe, effective care to patients suffering from obesity and its resulting complications.”
Under his leadership, the practice has “developed into New York’s elite institution for obesity treatment,” Dr. Garber said. He said the group’s surgeons are “highly sought after to train other bariatric surgeons throughout the country and are active in the development of new, cutting-edge bariatric surgery techniques.”
In 2017, Dr. Garber and partners agreed on a business plan to help spur growth and “attract private equity investment,” according to the affidavit.
They formed a separate company to handle the bariatric practice’s business side. Known as management services organizations, such companies provide a way for private equity investors to circumvent laws in some states that prohibit nonphysicians from owning a stake in a medical practice.
In August 2019, the private equity firm Sentinel Capital Partners bought 65% of the MSO for $156.5 million, according to Dr. Garber’s affidavit. The management company is now known as New You Bariatric Group. The private equity firm did not respond to requests for comment.
Dr. Garber, in a September 2021 American Society for Metabolic and Bariatric Surgery webinar viewable online, said the weight-loss practice spends $6 million a year on media and marketing directly to patients – and is on a roll. Nationally, bariatric surgery is growing 6% annually, he said. NYBG boasts two dozen offices in the tri-state area of New York, New Jersey, and Connecticut and is poised to expand into more states.
“Since private equity, we’ve been growing at 30%-40% year over year,” Dr. Garber said.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Seven months after Lahavah Wallace’s weight-loss operation, a New York bariatric surgery practice sued her, accusing her of “intentionally” failing to pay nearly $18,000 of her bill.
Long Island Minimally Invasive Surgery, which does business as the New York Bariatric Group, went on to accuse Ms. Wallace of “embezzlement,” alleging she kept insurance payments that should have been turned over to the practice.
Ms. Wallace denies the allegations, which the bariatric practice has leveled against patients in hundreds of debt-collection lawsuits filed over the past 4 years, court records in New York state show.
In about 60 cases, the lawsuits demanded $100,000 or more from patients. Some patients were found liable for tens of thousands of dollars in interest charges or wound up shackled with debt that could take a decade or more to shake. Others are facing the likely prospect of six-figure financial penalties, court records show.
Backed by a major private equity firm, the bariatric practice spends millions each year on advertisements featuring patients who have dropped 100 pounds or more after bariatric procedures, sometimes having had a portion of their stomachs removed. The ads have run on TV, online, and on New York City subway posters.
The online ads, often showcasing the slogan “Stop obesity for life,” appealed to Ms. Wallace, who lives in Brooklyn and works as a legal assistant for the state of New York. She said she turned over checks from her insurer to the bariatric group and was stunned when the medical practice hauled her into court citing an “out-of-network payment agreement” she had signed before her surgery.
“I really didn’t know what I was signing,” Ms. Wallace told KFF Health News. “I didn’t pay enough attention.”
Shawn Garber, MD, a bariatric surgeon who founded the practice in 2000 on Long Island and serves as its CEO, said that “prior to rendering services” his office staff advises patients of the costs and their responsibility to pay the bill.
The bariatric group has cited these out-of-network payment agreements in at least 300 lawsuits filed against patients from January 2019 to 2022 demanding nearly $19 million to cover medical bills, interest charges, and attorney’s fees, a KFF Health News review of New York state court records found.
Danny De Voe, a partner at Sahn Ward Braff Koblenz law firm in Uniondale, N.Y., who filed many of those suits, declined to comment, citing attorney-client privilege.
In most cases, the medical practice had agreed to accept an insurance company’s out-of-network rate as full payment for its services – with caveats, according to court filings.
In the agreements they signed, patients promised to pay any coinsurance, meeting any deductible, and pass on to the medical practice any reimbursement checks they received from their health plans within 7 days.
KFF Health News found – while legal fees and other costs can layer on thousands more.
Elisabeth Benjamin, a lawyer with the Community Service Society of New York, said conflicts can arise when insurers send checks to pay for out-of-network medical services to patients rather than reimbursing a medical provider directly.
“We would prefer to see regulators step in and stop that practice,” she said, adding it “causes tension between providers and patients.”
That’s certainly true for Ms. Wallace. The surgery practice sued her in August 2022demanding $17,981 in fees it said remained unpaid after her January 2022 laparoscopic sleeve gastrectomy, an operation in which much of the stomach is removed to assist weight loss.
The lawsuit also tacked on a demand for $5,993 in attorney’s fees, court records show.
The suit alleges Ms. Wallace signed the contract even though she “had no intention” of paying her bills. The complaint goes on to accuse her of “committing embezzlement” by “willfully, intentionally, deliberately and maliciously” depositing checks from her health plan into her personal account.
The suit doesn’t include details to substantiate these claims, and Ms. Wallace said in her court response they are not true. Ms. Wallace said she turned over checks for the charges.
“They billed the insurance for everything they possibly could,” Ms. Wallace said.
In September, Ms. Wallace filed for bankruptcy, hoping to discharge the bariatric care debt along with about $4,700 in unrelated credit card charges.
The medical practice fired back in November by filing an “adversary complaint” in her Brooklyn bankruptcy court proceeding that argues her medical debt should not be forgiven because Ms. Wallace committed fraud.
The adversary complaint, which is pending in the bankruptcy case, accuses Ms. Wallace of “fraudulently” inducing the surgery center to perform “elective medical procedures” without requiring payment up front.
Both the harsh wording and claims of wrongdoing have infuriated Ms. Wallace and her attorney, Jacob Silver, of Brooklyn.
Mr. Silver wants the medical practice to turn over records of the payments received from Ms. Wallace. “There is no fraud here,” he said. “This is frivolous. We are taking a no-settlement position.”
Gaining debt
Few patients sued by the bariatric practice mount a defense in court and those who do fight often lose, court records show.
The medical practice won default judgments totaling nearly $6 million in about 90 of the 300 cases in the sample reviewed by KFF Health News. Default judgments are entered when the defendant fails to respond.
Many cases either are pending, or it is not clear from court filings how they were resolved.
Some patients tried to argue that the fees were too high or that they didn’t understand going in how much they could owe. One woman, trying to push back against a demand for more than $100,000, said in a legal filing that she “was given numerous papers to sign without anyone of the staff members explaining to me what it actually meant.” Another patient, who was sued for more than $40,000, wrote: “I don’t have the means to pay this bill.”
Among the cases described in court records:
- A Westchester County, N.Y., woman was sued for $102,556 and settled for $72,000 in May 2021. She agreed to pay $7,500 upon signing the settlement and $500 a month from September 2021 to May 2032.
- A Peekskill, N.Y., woman in a December 2019 judgment was held liable for $384,092, which included $94,047 in interest.
- A Newburgh, N.Y., man was sued in 2021 for $252,309 in medical bills, 12% interest, and $84,103 in attorneys’ fees. The case is pending.
Robert Cohen, a longtime attorney for the bariatric practice, testified in a November 2021 hearing that the lawyers take “a contingency fee of one-third of our recovery” in these cases. In that case, Mr. Cohen had requested $13,578 based on his contingency fee arrangement. He testified that he spent 7.3 hours on the case and that his customary billing rate was $475 per hour, which came to $3,467.50. The judge awarded the lower amount, according to a transcript of the hearing.
Teresa LaMasters, MD, president of the American Society for Metabolic and Bariatric Surgery, said suing patients for large sums “is not a common practice” among bariatric surgeons.
“This is not what the vast majority in the field would espouse,” she said.
But Dr. Garber, the NYBG’s chief executive, suggested patients deserve blame.
“These lawsuits stem from these patients stealing the insurance money rather than forwarding it onto NYBG as they are morally and contractually obligated to do,” Dr. Garber wrote in an email to KFF Health News.
Dr. Garber added: “The issue is not with what we bill, but rather with the fact that the insurance companies refuse to send payment directly to us.”
‘A kooky system’
Defense attorneys argue that many patients don’t fully comprehend the perils of failing to pay on time – for whatever reason.
In a few cases, patients admitted pocketing checks they were obligated to turn over to the medical practice. But for the most part, court records don’t specify how many such checks were issued and for what amounts – or whether the patient improperly cashed them.
“It’s a kooky system,” said Paul Brite, an attorney who has faced off against the bariatric practice in court.
“You sign these documents that could cost you tons of money. It shouldn’t be that way,” he said. “This can ruin their financial life.”
New York lawmakers have acted to limit the damage from medical debt, including “surprise bills.”
In November, Democratic Gov. Kathy Hochul signed legislation that prohibits health care providers from slapping liens on a primary residence or garnishing wages.
But contracts with onerous repayment terms represent an “evolving area of law” and an alarming “new twist” on concerns over medical debt, said Ms. Benjamin, the community service society lawyer.
She said contract “accelerator clauses” that trigger severe penalties if patients miss payments should not be permitted for medical debt.
“If you default, the full amount is due,” she said. “This is really a bummer.”
‘Fair market value’
The debt collection lawsuits argue that weight-loss patients had agreed to pay “fair market value” for services – and the doctors are only trying to secure money they are due.
But some prices far exceed typical insurance payments for obesity treatments across the country, according to a medical billing data registry. Surgeons performed about 200,000 bariatric operations in 2020, according to the bariatric surgery society.
Ms. Wallace, the Brooklyn legal assistant, was billed $60,500 for her lap sleeve gastrectomy, though how much her insurance actually paid remains to be hashed out in court.
Michael Arrigo, a California medical billing expert at No World Borders, called the prices “outrageous” and “unreasonable and, in fact, likely unconscionable.”
“I disagree that these are fair market charges,” he said.
Dr. LaMasters called the gastrectomy price billed to Ms. Wallace “really expensive” and “a severe outlier.” While charges vary by region, she quoted a typical price of around $22,000.
Dr. Garber said NYBG “bills at usual and customary rates” determined by Fair Health, a New York City-based repository of insurance claims data. Fair Health “sets these rates based upon the acceptable price for our geographic location,” he said.
But Rachel Kent, Fair Health’s senior director of marketing, told KFF Health News that the group “does not set rates, nor determine or take any position on what constitutes ‘usual and customary rates.’ ” Instead, it reports the prices providers are charging in a given area.
Overall, Fair Health data shows huge price variations even in adjacent ZIP codes in the metro area. In Long Island’s Roslyn Heights neighborhood, where NYBG is based, Fair Health lists the out-of-network price charged by providers in the area as $60,500, the figure Ms. Wallace was billed.
But in several other New York City–area ZIP codes the price charged for the gastrectomy procedure hovers around $20,000, according to the data bank. The price in Manhattan is $17,500, for instance, according to Fair Health.
Nationwide, the average cost in 2021 for bariatric surgery done in a hospital was $32,868, according to a KFF analysis of health insurance claims.
Private equity arrives
Dr. Garber said in a court affidavit in May 2022 that he founded the bariatric practice “with a singular focus: providing safe, effective care to patients suffering from obesity and its resulting complications.”
Under his leadership, the practice has “developed into New York’s elite institution for obesity treatment,” Dr. Garber said. He said the group’s surgeons are “highly sought after to train other bariatric surgeons throughout the country and are active in the development of new, cutting-edge bariatric surgery techniques.”
In 2017, Dr. Garber and partners agreed on a business plan to help spur growth and “attract private equity investment,” according to the affidavit.
They formed a separate company to handle the bariatric practice’s business side. Known as management services organizations, such companies provide a way for private equity investors to circumvent laws in some states that prohibit nonphysicians from owning a stake in a medical practice.
In August 2019, the private equity firm Sentinel Capital Partners bought 65% of the MSO for $156.5 million, according to Dr. Garber’s affidavit. The management company is now known as New You Bariatric Group. The private equity firm did not respond to requests for comment.
Dr. Garber, in a September 2021 American Society for Metabolic and Bariatric Surgery webinar viewable online, said the weight-loss practice spends $6 million a year on media and marketing directly to patients – and is on a roll. Nationally, bariatric surgery is growing 6% annually, he said. NYBG boasts two dozen offices in the tri-state area of New York, New Jersey, and Connecticut and is poised to expand into more states.
“Since private equity, we’ve been growing at 30%-40% year over year,” Dr. Garber said.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Medicare fines for high hospital readmissions drop, but nearly 2,300 facilities are still penalized
resulting in the lightest penalties since 2014.
The Hospital Readmissions Reduction Program has been a mainstay of Medicare’s hospital payment system since it began in 2012. Created by the Affordable Care Act, the program evaluates the frequency with which Medicare patients at most hospitals return within 30 days and lowers future payments to hospitals that had a greater-than-expected rate of return. Hospitals can lose up to 3% of each Medicare payment for a year.
The pandemic threw hospitals into turmoil, inundating them with COVID patients while forcing many to postpone elective surgeries for months. When the Centers for Medicare & Medicaid Services evaluated hospitals’ previous 3 years of readmissions, as it does annually, the government decided to exclude the first half of 2020 because of the chaos caused by the pandemic. CMS also excluded from its calculations Medicare patients who were readmitted with pneumonia across all three years because of the difficulty in distinguishing them from patients with COVID.
Akin Demehin, senior director of quality and patient safety policy at the American Hospital Association, said the changes were warranted. “The COVID pandemic did a lot of really unprecedented things to care patterns of hospitals,” he said.
After making those changes, CMS evaluated 2½ years of readmission cases for Medicare patients who’d had heart failure, heart attacks, chronic obstructive pulmonary disease, coronary artery bypass grafts, and knee and hip replacements. As a result of its analysis, CMS penalized 2,273 hospitals, the fewest since the fiscal year that ended in September 2014, a KHN analysis found.
The average payment reduction was 0.43%, also the lowest since 2014. The reductions will be applied to each Medicare payment to the affected hospitals from Oct. 1 to next September and cost them $320 million over that 12-month period.
Some hospitals will see their penalties greatly reduced from 2021. The penalty on St. Mary’s Hospital in Athens, Ga., is dropping from 2.54% to 0.06%. Saint Joseph East in Lexington, Ky., received the maximum penalty, 3%, in 2021; it will lose 0.78% as of Oct. 1. In Flemington, N.J., the penalty for Hunterdon Medical Center is dropping from 2.29% to 0.12%.
To limit penalties, many hospitals in recent years have instituted new strategies to keep former patients from needing a return visit. Robert Coates, MD, interim chief medical officer at Hunterdon Health, which owns Hunterdon Medical Center, said in a statement that the hospital set up a system to identify patients who visited the emergency room within 30 days of a hospital stay. Instead of readmitting them, Hunterdon helps them set up next-day appointments at a doctor’s office or home monitoring of their health. Hunterdon also calls all discharged patients to ensure they have filled their prescriptions and had a follow-up visit with a clinician within a week of leaving the hospital.
Jessica Satterfield, MD, director of quality and clinical excellence at St. Mary’s Health Care System, which operates St. Mary’s Hospital, said in a statement that the hospital identified patients at risk of readmission when they were first admitted and focused on making sure that their medications were correct and that they had follow-up visits. “We are proud that our efforts are bearing fruit in the form of greatly reduced penalties but, more importantly, as a reflection of the exceptional care our staff and medical staff provide to our patients,” Dr. Satterfield said.
Saint Joseph East did not respond to emails seeking comment.
Despite the changes, 43% of the nation’s 5,236 hospitals were penalized. Of the unpenalized, all but 770 were automatically exempted. The 2,193 exempted hospitals include those that specialize in children, psychiatric patients, or veterans. Rehabilitation and long-term care hospitals are also excluded from the program, as are critical access hospitals, which Medicare pays differently to help them stay open in areas with no other hospitals. The government also exempted Maryland hospitals because that state has a special payment arrangement with Medicare. Of the hospitals that Medicare assessed, 75% were penalized.
For the new fiscal year, Medicare also cited the pandemic in giving hospitals a reprieve from its other major quality-focused effort that assesses penalties: the Hospital-Acquired Condition Reduction Program. It slashes Medicare payments by 1% to the quarter of general hospitals with the highest rates of infections and other potentially preventable patient injuries. For the previous fiscal year, CMS punished 764 hospitals under that program. Those penalties – which would have cost hospitals an estimated $350 million in 2022 – will resume next fiscal year, with adjustments that better take COVID patients into account. CMS will also refine the readmissions penalty program to distinguish pneumonia patients from COVID patients.
“COVID has been a tremendously disruptive force for all aspects of health care, most certainly CMS’ quality measurement programs,” Mr. Demehin said. “It’s probably going to be a couple of volatile years for readmission penalties.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
resulting in the lightest penalties since 2014.
The Hospital Readmissions Reduction Program has been a mainstay of Medicare’s hospital payment system since it began in 2012. Created by the Affordable Care Act, the program evaluates the frequency with which Medicare patients at most hospitals return within 30 days and lowers future payments to hospitals that had a greater-than-expected rate of return. Hospitals can lose up to 3% of each Medicare payment for a year.
The pandemic threw hospitals into turmoil, inundating them with COVID patients while forcing many to postpone elective surgeries for months. When the Centers for Medicare & Medicaid Services evaluated hospitals’ previous 3 years of readmissions, as it does annually, the government decided to exclude the first half of 2020 because of the chaos caused by the pandemic. CMS also excluded from its calculations Medicare patients who were readmitted with pneumonia across all three years because of the difficulty in distinguishing them from patients with COVID.
Akin Demehin, senior director of quality and patient safety policy at the American Hospital Association, said the changes were warranted. “The COVID pandemic did a lot of really unprecedented things to care patterns of hospitals,” he said.
After making those changes, CMS evaluated 2½ years of readmission cases for Medicare patients who’d had heart failure, heart attacks, chronic obstructive pulmonary disease, coronary artery bypass grafts, and knee and hip replacements. As a result of its analysis, CMS penalized 2,273 hospitals, the fewest since the fiscal year that ended in September 2014, a KHN analysis found.
The average payment reduction was 0.43%, also the lowest since 2014. The reductions will be applied to each Medicare payment to the affected hospitals from Oct. 1 to next September and cost them $320 million over that 12-month period.
Some hospitals will see their penalties greatly reduced from 2021. The penalty on St. Mary’s Hospital in Athens, Ga., is dropping from 2.54% to 0.06%. Saint Joseph East in Lexington, Ky., received the maximum penalty, 3%, in 2021; it will lose 0.78% as of Oct. 1. In Flemington, N.J., the penalty for Hunterdon Medical Center is dropping from 2.29% to 0.12%.
To limit penalties, many hospitals in recent years have instituted new strategies to keep former patients from needing a return visit. Robert Coates, MD, interim chief medical officer at Hunterdon Health, which owns Hunterdon Medical Center, said in a statement that the hospital set up a system to identify patients who visited the emergency room within 30 days of a hospital stay. Instead of readmitting them, Hunterdon helps them set up next-day appointments at a doctor’s office or home monitoring of their health. Hunterdon also calls all discharged patients to ensure they have filled their prescriptions and had a follow-up visit with a clinician within a week of leaving the hospital.
Jessica Satterfield, MD, director of quality and clinical excellence at St. Mary’s Health Care System, which operates St. Mary’s Hospital, said in a statement that the hospital identified patients at risk of readmission when they were first admitted and focused on making sure that their medications were correct and that they had follow-up visits. “We are proud that our efforts are bearing fruit in the form of greatly reduced penalties but, more importantly, as a reflection of the exceptional care our staff and medical staff provide to our patients,” Dr. Satterfield said.
Saint Joseph East did not respond to emails seeking comment.
Despite the changes, 43% of the nation’s 5,236 hospitals were penalized. Of the unpenalized, all but 770 were automatically exempted. The 2,193 exempted hospitals include those that specialize in children, psychiatric patients, or veterans. Rehabilitation and long-term care hospitals are also excluded from the program, as are critical access hospitals, which Medicare pays differently to help them stay open in areas with no other hospitals. The government also exempted Maryland hospitals because that state has a special payment arrangement with Medicare. Of the hospitals that Medicare assessed, 75% were penalized.
For the new fiscal year, Medicare also cited the pandemic in giving hospitals a reprieve from its other major quality-focused effort that assesses penalties: the Hospital-Acquired Condition Reduction Program. It slashes Medicare payments by 1% to the quarter of general hospitals with the highest rates of infections and other potentially preventable patient injuries. For the previous fiscal year, CMS punished 764 hospitals under that program. Those penalties – which would have cost hospitals an estimated $350 million in 2022 – will resume next fiscal year, with adjustments that better take COVID patients into account. CMS will also refine the readmissions penalty program to distinguish pneumonia patients from COVID patients.
“COVID has been a tremendously disruptive force for all aspects of health care, most certainly CMS’ quality measurement programs,” Mr. Demehin said. “It’s probably going to be a couple of volatile years for readmission penalties.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
resulting in the lightest penalties since 2014.
The Hospital Readmissions Reduction Program has been a mainstay of Medicare’s hospital payment system since it began in 2012. Created by the Affordable Care Act, the program evaluates the frequency with which Medicare patients at most hospitals return within 30 days and lowers future payments to hospitals that had a greater-than-expected rate of return. Hospitals can lose up to 3% of each Medicare payment for a year.
The pandemic threw hospitals into turmoil, inundating them with COVID patients while forcing many to postpone elective surgeries for months. When the Centers for Medicare & Medicaid Services evaluated hospitals’ previous 3 years of readmissions, as it does annually, the government decided to exclude the first half of 2020 because of the chaos caused by the pandemic. CMS also excluded from its calculations Medicare patients who were readmitted with pneumonia across all three years because of the difficulty in distinguishing them from patients with COVID.
Akin Demehin, senior director of quality and patient safety policy at the American Hospital Association, said the changes were warranted. “The COVID pandemic did a lot of really unprecedented things to care patterns of hospitals,” he said.
After making those changes, CMS evaluated 2½ years of readmission cases for Medicare patients who’d had heart failure, heart attacks, chronic obstructive pulmonary disease, coronary artery bypass grafts, and knee and hip replacements. As a result of its analysis, CMS penalized 2,273 hospitals, the fewest since the fiscal year that ended in September 2014, a KHN analysis found.
The average payment reduction was 0.43%, also the lowest since 2014. The reductions will be applied to each Medicare payment to the affected hospitals from Oct. 1 to next September and cost them $320 million over that 12-month period.
Some hospitals will see their penalties greatly reduced from 2021. The penalty on St. Mary’s Hospital in Athens, Ga., is dropping from 2.54% to 0.06%. Saint Joseph East in Lexington, Ky., received the maximum penalty, 3%, in 2021; it will lose 0.78% as of Oct. 1. In Flemington, N.J., the penalty for Hunterdon Medical Center is dropping from 2.29% to 0.12%.
To limit penalties, many hospitals in recent years have instituted new strategies to keep former patients from needing a return visit. Robert Coates, MD, interim chief medical officer at Hunterdon Health, which owns Hunterdon Medical Center, said in a statement that the hospital set up a system to identify patients who visited the emergency room within 30 days of a hospital stay. Instead of readmitting them, Hunterdon helps them set up next-day appointments at a doctor’s office or home monitoring of their health. Hunterdon also calls all discharged patients to ensure they have filled their prescriptions and had a follow-up visit with a clinician within a week of leaving the hospital.
Jessica Satterfield, MD, director of quality and clinical excellence at St. Mary’s Health Care System, which operates St. Mary’s Hospital, said in a statement that the hospital identified patients at risk of readmission when they were first admitted and focused on making sure that their medications were correct and that they had follow-up visits. “We are proud that our efforts are bearing fruit in the form of greatly reduced penalties but, more importantly, as a reflection of the exceptional care our staff and medical staff provide to our patients,” Dr. Satterfield said.
Saint Joseph East did not respond to emails seeking comment.
Despite the changes, 43% of the nation’s 5,236 hospitals were penalized. Of the unpenalized, all but 770 were automatically exempted. The 2,193 exempted hospitals include those that specialize in children, psychiatric patients, or veterans. Rehabilitation and long-term care hospitals are also excluded from the program, as are critical access hospitals, which Medicare pays differently to help them stay open in areas with no other hospitals. The government also exempted Maryland hospitals because that state has a special payment arrangement with Medicare. Of the hospitals that Medicare assessed, 75% were penalized.
For the new fiscal year, Medicare also cited the pandemic in giving hospitals a reprieve from its other major quality-focused effort that assesses penalties: the Hospital-Acquired Condition Reduction Program. It slashes Medicare payments by 1% to the quarter of general hospitals with the highest rates of infections and other potentially preventable patient injuries. For the previous fiscal year, CMS punished 764 hospitals under that program. Those penalties – which would have cost hospitals an estimated $350 million in 2022 – will resume next fiscal year, with adjustments that better take COVID patients into account. CMS will also refine the readmissions penalty program to distinguish pneumonia patients from COVID patients.
“COVID has been a tremendously disruptive force for all aspects of health care, most certainly CMS’ quality measurement programs,” Mr. Demehin said. “It’s probably going to be a couple of volatile years for readmission penalties.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Tech Glitches at One VA Site Raise Concerns About a Nationwide Rollout
Spokane, Washington, was supposed to be the center of the Department of Veterans Affairs’ tech reinvention, the first site in the agency’s decade-long project to change its medical records software. But one morning in early March, the latest system malfunction made some clinicians snap.
At Spokane’s Mann-Grandstaff VA Medical Center, the records system — developed by Cerner Corp., based in North Kansas City, Missouri — went down. Staffers, inside the hospital and its outpatient facilities, were back to relying on pen and paper. Computerized schedules were inaccessible. Physicians couldn’t enter new orders or change patients’ medications.
By the next day, the electronic health records were only partially available. Dozens of records remained “sequestered,” meaning that doctors and nurses struggled to update patient charts.
The snafu, the latest in a series at Mann-Grandstaff, heightened Spokane medical staff members’ frustration with a system that has been problematic since it was installed a year and a half ago. The VA said no patients had been harmed because of the problems.
But physicians on the ground there said it’s only a matter of time before serious safety problems — those causing injury or death — emerge, pointing to the program’s ongoing weaknesses amid VA leadership’s full-bore push toward implementation nationwide. One provider said she was glad she didn’t have a relative in Mann-Grandstaff.
The one-two punch of a dangerous outage and staff grievances is the latest setback in the VA’s more than $16 billion effort to upgrade its record-keeping technology. The issues have at times forced clinicians to see fewer patients and file tens of thousands of requests for help to Cerner with patient-safety problems, congressional and agency watchdog reviews show.
If those issues multiply over the vast VA system — which employs more than a quarter-million workers and serves 6.3 million active patients — it could create rampant patient-safety and productivity problems. Despite the VA’s goals of using the technology upgrade to provide seamless records for patients from enlistment in the military until discharge, the doctors and clinicians who spoke to KHN are convinced that the problems experienced in Spokane will be repeated again and again.
The records system, scheduled for deployment at multiple VA facilities in the Pacific Northwest in the coming weeks and months, most recently rolled out at Jonathan M. Wainwright Memorial VA Medical Center in Walla Walla, Washington.
Both Cerner and Mann-Grandstaff officials declined to comment and referred KHN to officials at VA headquarters in Washington, D.C.
“If it’s a total meltdown” in Walla Walla, said Katie Purswell, the American Legion’s director of veterans affairs and rehabilitation, it’s a problem for the department and its decade-long initiative. Initial impressions from staffers are positive, but the issues in Spokane appeared over the course of weeks after the system was turned on.
The distress was particularly acute in early March. On March 2, Cerner turned on a software update to a database containing patient identification information. Problems emerged the next morning. In the record of a patient who was checking in for surgery, staff members discovered incorrect data, including gender information for a different patient. About an hour later, a staffer from the national VA’s medical records office told some clinicians at Mann-Grandstaff to “log out.”
Robert Fischer, Mann-Grandstaff’s medical center director, sent a dire warning later that morning. “Assume all electronic data is corrupted/inaccurate,” Fischer said in an email. He urged clinicians to limit orders for lab work, imaging studies, and medications. The facility shifted to “downtime procedures,” meaning a reliance on paper.
Some staffers didn’t absorb the late-morning message and continued entering information in the mixed-up records, adding to the stew of erroneous data.
According to information provided to Congress later by the VA, Cerner had informed Mann-Grandstaff of a “complete degradation” the night before — leading to questions from staffers about why it took until late morning the next day to shut down the system. Agency spokesperson Erin Crowe told KHN there wasn’t any delay in notifying staff.
Problems stretched into the following week. Some records — 70 as of March 10, according to a briefing provided to Congress — remained unusable while auditors tried to ascertain what information had been mixed in from other charts. This left clinicians in some instances unable to keep track of patients’ care. Doctors said it became a confusing and chaotic environment. They couldn’t, for example, help patients refill prescriptions.
Members of Congress are concerned — not only about the outage but also VA’s explanations about it. In a letter to agency leadership, the leading Republicans on the House Veterans’ Affairs Committee and the subcommittee overseeing technology, Rep. Mike Bost of Illinois and Rep. Matt Rosendale of Montana, expressed worries the agency was “soft-pedal[ing]” its communications and argued that veterans were misled by assurances that records had been corrected.
The full committee plans to do a deeper examination soon. It has scheduled a closed-door roundtable with VA staffers from Spokane and Walla Walla on April 5.
The outage deepened unhappiness at Mann-Grandstaff. Clinicians there were already frazzled by a deeply buggy system. Downtime was common, a congressional aide told KHN.
A March 17 VA inspector general report documented nearly 39,000 requests for technical help or improvement since the October 2020 deployment of the new records system. Cerner employees often closed requests without resolving the underlying problems, the report said. Mann-Grandstaff staffers became disengaged or devised shortcuts to bypass the malfunctioning software, the inspector general wrote — each a potential root of patient-safety incidents.
The department said the shortcuts — or workarounds — aren’t its policy. “Workarounds are not authorized nor encouraged,” Crowe said.
The Biden administration tried to overhaul the software initiative, putting the program on hiatus before installing new leadership in the medical records office at the end of 2021. But by then, low morale had sunk in. “People in Spokane VA are … demoralized and unhappy,” Rep. Frank Mrvan (D-Ind.), chair of the House subcommittee focused on the VA’s technology modernization programs, told agency leaders during a November congressional hearing. He said staffers told him they felt as though they were beating their heads against a wall to make things function.
Other observers shared Mrvan’s concerns.
Purswell of the American Legion questioned whether appropriate steps are being taken to prepare the Walla Walla facility and its staff for the technology rollout. She asked whether staffers feel as if the Cerner system has been thrust upon them or are excited about the change.
Whether the VA has been persuasive about the benefits of the program is unclear. “I think it’s incumbent on us to demonstrate it’s not a loss,” said Dr. Terry Adirim, the leader of the VA office in charge of implementing the new records technology. “We might have dropped the ball on explaining what a benefit this is.”
Indeed, Adirim conducted a virtual town hall meeting March 21 for veterans in the Walla Walla area — where she was pressed about the problems in Spokane. “If Spokane has been a year figuring this out, why is this moving forward?” one questioner asked, expressing a point made frequently during the call. Adirim said the VA had made “thousands of changes” since the initial rollout.
Medical staffers at the Spokane and Walla Walla VA facilities are part of informal networks sharing their often-negative experiences about the program despite a perception among staff members that dissent will hurt their careers.
Adirim thinks negative feelings can be addressed by stepping up technical support. She also said training programs have been overhauled since the deployment in Spokane. Bottom line: The VA is proceeding.
“People want to revert back to what they did before,” Adirim said, but that’s not going to happen.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Subscribe to KHN's free Morning Briefing.
Spokane, Washington, was supposed to be the center of the Department of Veterans Affairs’ tech reinvention, the first site in the agency’s decade-long project to change its medical records software. But one morning in early March, the latest system malfunction made some clinicians snap.
At Spokane’s Mann-Grandstaff VA Medical Center, the records system — developed by Cerner Corp., based in North Kansas City, Missouri — went down. Staffers, inside the hospital and its outpatient facilities, were back to relying on pen and paper. Computerized schedules were inaccessible. Physicians couldn’t enter new orders or change patients’ medications.
By the next day, the electronic health records were only partially available. Dozens of records remained “sequestered,” meaning that doctors and nurses struggled to update patient charts.
The snafu, the latest in a series at Mann-Grandstaff, heightened Spokane medical staff members’ frustration with a system that has been problematic since it was installed a year and a half ago. The VA said no patients had been harmed because of the problems.
But physicians on the ground there said it’s only a matter of time before serious safety problems — those causing injury or death — emerge, pointing to the program’s ongoing weaknesses amid VA leadership’s full-bore push toward implementation nationwide. One provider said she was glad she didn’t have a relative in Mann-Grandstaff.
The one-two punch of a dangerous outage and staff grievances is the latest setback in the VA’s more than $16 billion effort to upgrade its record-keeping technology. The issues have at times forced clinicians to see fewer patients and file tens of thousands of requests for help to Cerner with patient-safety problems, congressional and agency watchdog reviews show.
If those issues multiply over the vast VA system — which employs more than a quarter-million workers and serves 6.3 million active patients — it could create rampant patient-safety and productivity problems. Despite the VA’s goals of using the technology upgrade to provide seamless records for patients from enlistment in the military until discharge, the doctors and clinicians who spoke to KHN are convinced that the problems experienced in Spokane will be repeated again and again.
The records system, scheduled for deployment at multiple VA facilities in the Pacific Northwest in the coming weeks and months, most recently rolled out at Jonathan M. Wainwright Memorial VA Medical Center in Walla Walla, Washington.
Both Cerner and Mann-Grandstaff officials declined to comment and referred KHN to officials at VA headquarters in Washington, D.C.
“If it’s a total meltdown” in Walla Walla, said Katie Purswell, the American Legion’s director of veterans affairs and rehabilitation, it’s a problem for the department and its decade-long initiative. Initial impressions from staffers are positive, but the issues in Spokane appeared over the course of weeks after the system was turned on.
The distress was particularly acute in early March. On March 2, Cerner turned on a software update to a database containing patient identification information. Problems emerged the next morning. In the record of a patient who was checking in for surgery, staff members discovered incorrect data, including gender information for a different patient. About an hour later, a staffer from the national VA’s medical records office told some clinicians at Mann-Grandstaff to “log out.”
Robert Fischer, Mann-Grandstaff’s medical center director, sent a dire warning later that morning. “Assume all electronic data is corrupted/inaccurate,” Fischer said in an email. He urged clinicians to limit orders for lab work, imaging studies, and medications. The facility shifted to “downtime procedures,” meaning a reliance on paper.
Some staffers didn’t absorb the late-morning message and continued entering information in the mixed-up records, adding to the stew of erroneous data.
According to information provided to Congress later by the VA, Cerner had informed Mann-Grandstaff of a “complete degradation” the night before — leading to questions from staffers about why it took until late morning the next day to shut down the system. Agency spokesperson Erin Crowe told KHN there wasn’t any delay in notifying staff.
Problems stretched into the following week. Some records — 70 as of March 10, according to a briefing provided to Congress — remained unusable while auditors tried to ascertain what information had been mixed in from other charts. This left clinicians in some instances unable to keep track of patients’ care. Doctors said it became a confusing and chaotic environment. They couldn’t, for example, help patients refill prescriptions.
Members of Congress are concerned — not only about the outage but also VA’s explanations about it. In a letter to agency leadership, the leading Republicans on the House Veterans’ Affairs Committee and the subcommittee overseeing technology, Rep. Mike Bost of Illinois and Rep. Matt Rosendale of Montana, expressed worries the agency was “soft-pedal[ing]” its communications and argued that veterans were misled by assurances that records had been corrected.
The full committee plans to do a deeper examination soon. It has scheduled a closed-door roundtable with VA staffers from Spokane and Walla Walla on April 5.
The outage deepened unhappiness at Mann-Grandstaff. Clinicians there were already frazzled by a deeply buggy system. Downtime was common, a congressional aide told KHN.
A March 17 VA inspector general report documented nearly 39,000 requests for technical help or improvement since the October 2020 deployment of the new records system. Cerner employees often closed requests without resolving the underlying problems, the report said. Mann-Grandstaff staffers became disengaged or devised shortcuts to bypass the malfunctioning software, the inspector general wrote — each a potential root of patient-safety incidents.
The department said the shortcuts — or workarounds — aren’t its policy. “Workarounds are not authorized nor encouraged,” Crowe said.
The Biden administration tried to overhaul the software initiative, putting the program on hiatus before installing new leadership in the medical records office at the end of 2021. But by then, low morale had sunk in. “People in Spokane VA are … demoralized and unhappy,” Rep. Frank Mrvan (D-Ind.), chair of the House subcommittee focused on the VA’s technology modernization programs, told agency leaders during a November congressional hearing. He said staffers told him they felt as though they were beating their heads against a wall to make things function.
Other observers shared Mrvan’s concerns.
Purswell of the American Legion questioned whether appropriate steps are being taken to prepare the Walla Walla facility and its staff for the technology rollout. She asked whether staffers feel as if the Cerner system has been thrust upon them or are excited about the change.
Whether the VA has been persuasive about the benefits of the program is unclear. “I think it’s incumbent on us to demonstrate it’s not a loss,” said Dr. Terry Adirim, the leader of the VA office in charge of implementing the new records technology. “We might have dropped the ball on explaining what a benefit this is.”
Indeed, Adirim conducted a virtual town hall meeting March 21 for veterans in the Walla Walla area — where she was pressed about the problems in Spokane. “If Spokane has been a year figuring this out, why is this moving forward?” one questioner asked, expressing a point made frequently during the call. Adirim said the VA had made “thousands of changes” since the initial rollout.
Medical staffers at the Spokane and Walla Walla VA facilities are part of informal networks sharing their often-negative experiences about the program despite a perception among staff members that dissent will hurt their careers.
Adirim thinks negative feelings can be addressed by stepping up technical support. She also said training programs have been overhauled since the deployment in Spokane. Bottom line: The VA is proceeding.
“People want to revert back to what they did before,” Adirim said, but that’s not going to happen.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Subscribe to KHN's free Morning Briefing.
Spokane, Washington, was supposed to be the center of the Department of Veterans Affairs’ tech reinvention, the first site in the agency’s decade-long project to change its medical records software. But one morning in early March, the latest system malfunction made some clinicians snap.
At Spokane’s Mann-Grandstaff VA Medical Center, the records system — developed by Cerner Corp., based in North Kansas City, Missouri — went down. Staffers, inside the hospital and its outpatient facilities, were back to relying on pen and paper. Computerized schedules were inaccessible. Physicians couldn’t enter new orders or change patients’ medications.
By the next day, the electronic health records were only partially available. Dozens of records remained “sequestered,” meaning that doctors and nurses struggled to update patient charts.
The snafu, the latest in a series at Mann-Grandstaff, heightened Spokane medical staff members’ frustration with a system that has been problematic since it was installed a year and a half ago. The VA said no patients had been harmed because of the problems.
But physicians on the ground there said it’s only a matter of time before serious safety problems — those causing injury or death — emerge, pointing to the program’s ongoing weaknesses amid VA leadership’s full-bore push toward implementation nationwide. One provider said she was glad she didn’t have a relative in Mann-Grandstaff.
The one-two punch of a dangerous outage and staff grievances is the latest setback in the VA’s more than $16 billion effort to upgrade its record-keeping technology. The issues have at times forced clinicians to see fewer patients and file tens of thousands of requests for help to Cerner with patient-safety problems, congressional and agency watchdog reviews show.
If those issues multiply over the vast VA system — which employs more than a quarter-million workers and serves 6.3 million active patients — it could create rampant patient-safety and productivity problems. Despite the VA’s goals of using the technology upgrade to provide seamless records for patients from enlistment in the military until discharge, the doctors and clinicians who spoke to KHN are convinced that the problems experienced in Spokane will be repeated again and again.
The records system, scheduled for deployment at multiple VA facilities in the Pacific Northwest in the coming weeks and months, most recently rolled out at Jonathan M. Wainwright Memorial VA Medical Center in Walla Walla, Washington.
Both Cerner and Mann-Grandstaff officials declined to comment and referred KHN to officials at VA headquarters in Washington, D.C.
“If it’s a total meltdown” in Walla Walla, said Katie Purswell, the American Legion’s director of veterans affairs and rehabilitation, it’s a problem for the department and its decade-long initiative. Initial impressions from staffers are positive, but the issues in Spokane appeared over the course of weeks after the system was turned on.
The distress was particularly acute in early March. On March 2, Cerner turned on a software update to a database containing patient identification information. Problems emerged the next morning. In the record of a patient who was checking in for surgery, staff members discovered incorrect data, including gender information for a different patient. About an hour later, a staffer from the national VA’s medical records office told some clinicians at Mann-Grandstaff to “log out.”
Robert Fischer, Mann-Grandstaff’s medical center director, sent a dire warning later that morning. “Assume all electronic data is corrupted/inaccurate,” Fischer said in an email. He urged clinicians to limit orders for lab work, imaging studies, and medications. The facility shifted to “downtime procedures,” meaning a reliance on paper.
Some staffers didn’t absorb the late-morning message and continued entering information in the mixed-up records, adding to the stew of erroneous data.
According to information provided to Congress later by the VA, Cerner had informed Mann-Grandstaff of a “complete degradation” the night before — leading to questions from staffers about why it took until late morning the next day to shut down the system. Agency spokesperson Erin Crowe told KHN there wasn’t any delay in notifying staff.
Problems stretched into the following week. Some records — 70 as of March 10, according to a briefing provided to Congress — remained unusable while auditors tried to ascertain what information had been mixed in from other charts. This left clinicians in some instances unable to keep track of patients’ care. Doctors said it became a confusing and chaotic environment. They couldn’t, for example, help patients refill prescriptions.
Members of Congress are concerned — not only about the outage but also VA’s explanations about it. In a letter to agency leadership, the leading Republicans on the House Veterans’ Affairs Committee and the subcommittee overseeing technology, Rep. Mike Bost of Illinois and Rep. Matt Rosendale of Montana, expressed worries the agency was “soft-pedal[ing]” its communications and argued that veterans were misled by assurances that records had been corrected.
The full committee plans to do a deeper examination soon. It has scheduled a closed-door roundtable with VA staffers from Spokane and Walla Walla on April 5.
The outage deepened unhappiness at Mann-Grandstaff. Clinicians there were already frazzled by a deeply buggy system. Downtime was common, a congressional aide told KHN.
A March 17 VA inspector general report documented nearly 39,000 requests for technical help or improvement since the October 2020 deployment of the new records system. Cerner employees often closed requests without resolving the underlying problems, the report said. Mann-Grandstaff staffers became disengaged or devised shortcuts to bypass the malfunctioning software, the inspector general wrote — each a potential root of patient-safety incidents.
The department said the shortcuts — or workarounds — aren’t its policy. “Workarounds are not authorized nor encouraged,” Crowe said.
The Biden administration tried to overhaul the software initiative, putting the program on hiatus before installing new leadership in the medical records office at the end of 2021. But by then, low morale had sunk in. “People in Spokane VA are … demoralized and unhappy,” Rep. Frank Mrvan (D-Ind.), chair of the House subcommittee focused on the VA’s technology modernization programs, told agency leaders during a November congressional hearing. He said staffers told him they felt as though they were beating their heads against a wall to make things function.
Other observers shared Mrvan’s concerns.
Purswell of the American Legion questioned whether appropriate steps are being taken to prepare the Walla Walla facility and its staff for the technology rollout. She asked whether staffers feel as if the Cerner system has been thrust upon them or are excited about the change.
Whether the VA has been persuasive about the benefits of the program is unclear. “I think it’s incumbent on us to demonstrate it’s not a loss,” said Dr. Terry Adirim, the leader of the VA office in charge of implementing the new records technology. “We might have dropped the ball on explaining what a benefit this is.”
Indeed, Adirim conducted a virtual town hall meeting March 21 for veterans in the Walla Walla area — where she was pressed about the problems in Spokane. “If Spokane has been a year figuring this out, why is this moving forward?” one questioner asked, expressing a point made frequently during the call. Adirim said the VA had made “thousands of changes” since the initial rollout.
Medical staffers at the Spokane and Walla Walla VA facilities are part of informal networks sharing their often-negative experiences about the program despite a perception among staff members that dissent will hurt their careers.
Adirim thinks negative feelings can be addressed by stepping up technical support. She also said training programs have been overhauled since the deployment in Spokane. Bottom line: The VA is proceeding.
“People want to revert back to what they did before,” Adirim said, but that’s not going to happen.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Subscribe to KHN's free Morning Briefing.
With sexually transmitted infections off the charts, California pushes at-home tests
SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.
The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.
By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.
“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”
But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.
Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.
“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”
Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.
The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.
In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.
Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.
Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.
Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.
The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.
Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.
The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.
“If insurance were to cover it, I’d definitely do it more,” he said.
Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.
Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.
Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.
The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.
The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.
Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.
Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.
Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.
The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.
Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.
Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.
“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.
Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.
“Going without it for so long was really hard on me,” Carrillo said.
This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.
The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.
By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.
“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”
But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.
Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.
“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”
Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.
The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.
In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.
Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.
Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.
Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.
The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.
Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.
The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.
“If insurance were to cover it, I’d definitely do it more,” he said.
Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.
Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.
Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.
The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.
The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.
Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.
Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.
Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.
The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.
Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.
Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.
“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.
Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.
“Going without it for so long was really hard on me,” Carrillo said.
This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.
The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.
By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.
“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”
But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.
Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.
“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”
Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.
The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.
In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.
Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.
Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.
Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.
The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.
Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.
The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.
“If insurance were to cover it, I’d definitely do it more,” he said.
Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.
Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.
Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.
The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.
The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.
Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.
Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.
Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.
The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.
Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.
Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.
“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.
Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.
“Going without it for so long was really hard on me,” Carrillo said.
This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Pandemic poses short- and long-term risks to babies, especially boys
The pandemic has created a hostile environment for pregnant people and their babies.
Stress levels among expectant mothers have soared. Pregnant women with COVID are 5 times as likely as uninfected pregnant people to require intensive care and 22 times as likely to die. Infected moms are four times as likely to have a stillborn child.
Yet some of the pandemic’s greatest threats to infants’ health may not be apparent for years or even decades.
That’s because babies of COVID-infected moms are 60% more likely to be born very prematurely, which increases the danger of infant mortality and long-term disabilities such as cerebral palsy, asthma, and hearing loss, as well as a child’s risk of adult disease, including depression, anxiety, heart disease, and kidney disease.
Studies have linked fever and infection during pregnancy to developmental and psychiatric conditions such as autism, depression, and schizophrenia.
“Some of these conditions do not show up until middle childhood or early adult life, but they have their origins in fetal life,” said Evdokia Anagnostou, MD, a child neurologist at Holland Bloorview Kids Rehabilitation Hospital and a pediatrics professor at the University of Toronto.
For fetuses exposed to COVID, the greatest danger is usually not the coronavirus itself, but the mother’s immune system.
Both severe COVID infections and the strain of the pandemic can expose fetuses to harmful inflammation, which can occur when a mother’s immune system is fighting a virus or when stress hormones send nonstop alarm signals.
Prenatal inflammation “changes the way the brain develops and, depending on the timing of the infection, it can change the way the heart or kidneys develop,” Dr. Anagnostou said.
Although health officials have strongly recommended COVID vaccines for pregnant people, only 35% are fully vaccinated.
At least 150,000 pregnant women have been diagnosed with COVID; more than 25,000 of them have been hospitalized, and 249 have died, according to the Centers for Disease Control and Prevention.
Although most babies will be fine, even a small increase in the percentage of children with special medical or educational needs could have a large effect on the population, given the huge number of COVID infections, Dr. Anagnostou said.
“If someone has a baby who is doing well, that is what they should focus on,” Dr. Anagnostou said. “But from a public health point of view, we need to follow women who experienced severe COVID and their babies to understand the impact.”
Learning from history
Researchers in the United States and other countries are already studying “the COVID generation” to see whether these children have more health issues than those conceived or born before 2020.
Previous crises have shown that the challenges fetuses face in the womb – such as maternal infections, hunger, stress, and hormone-disrupting chemicals – can leave a lasting imprint on their health, as well as that of their children and grandchildren, said Frederick Kaskel, MD, director of pediatric nephrology at the Children’s Hospital at Montefiore, New York.
People whose mothers were pregnant during surges in the 1918 influenza pandemic, for example, had poorer health throughout their lives, compared with Americans born at other times, said John McCarthy, who is a medical student at Albert Einstein College of Medicine, New York, and cowrote a recent review in JAMA Pediatrics with Dr. Kaskel.
Researchers don’t know exactly which moms were infected with pandemic flu, Mr. McCarthy said. But women who were pregnant during major surges – when infection was widespread – had children with higher rates of heart disease or diabetes. These children were also less successful in school, less economically productive, and more likely to live with a disability.
Because organ systems develop during different periods of pregnancy, fetuses exposed during the first trimester may face different risks than those exposed toward the end of pregnancy, Mr. McCarthy said. For example, people born in the fall of 1918 were 50% more likely than others to develop kidney disease; that may reflect an exposure to the pandemic in the third trimester, while the kidneys were still developing.
Nearly 2 years into the COVID pandemic, researchers have begun to publish preliminary observations of infants exposed to COVID infections and stress before birth.
Although Dr. Anagnostou noted that it’s too early to reach definitive conclusions, “there is evidence that babies born to moms with severe COVID infections have changes to their immune system,” she said. “It’s enough to make us worry a little bit.”
Damaging a fetal security system
The good news about the coronavirus is that it seldom crosses the placenta, the organ tasked with protecting a developing fetus from infections and providing it with oxygen. So moms with COVID rarely give the virus to their children before birth.
That’s important, because some viruses that directly infect the fetus – such as Zika – can cause devastating birth defects, said Karin Nielsen-Saines, MD, a specialist in pediatric infectious diseases at University of California, Los Angeles.
But studies also suggest that inflammation from a mother’s COVID infection can injure the placenta, said Jeffery Goldstein, MD, an assistant professor of pathology at Northwestern University, Chicago. In a study published in American Journal of Clinical Pathology , Dr. Goldstein and his coauthors found that placentas from COVID-infected moms had more abnormal blood vessels than placentas from patients without COVID, making it harder for them to deliver sufficient oxygen to the fetus.
Placental damage can also lead to preeclampsia, a serious complication of pregnancy that can cause a mother’s blood pressure to spike.
Preeclampsia occurs when blood vessels in the placenta don’t develop or function properly, forcing the mother’s heart to work harder to get blood to the fetus, which may not receive enough oxygen and nutrients. Preeclampsia also predisposes women to heart attacks and strokes later in life.
Rewiring the immune system
In some cases, COVID also appears to rewire a baby’s immune response, Dr. Nielsen-Saines said.
In an October study in the journal Cell Reports Medicine, Dr. Nielsen-Saines and her coauthors found that infants born to people with severe COVID infections had a different mix of immune cells and proteins than other babies. None of the newborns tested positive for the coronavirus.
The immune changes are concerning, Dr. Nielsen-Saines said, because this pattern of immune cells and proteins has previously been found in infants with respiratory problems and in some cases poor neurodevelopment.
Notably, all the babies in her study appear healthy, said Dr. Nielsen-Saines, who plans to follow them for 3 years to see whether these early signals translate into developmental delays, such as problems talking, walking, or interacting with others.
“How big of a difference does any of this make in the baby?” asked Dr. Anagnostou. “We won’t know for a few years. All we can do is try to be as prepared as possible.”
Increasing the risk for boys
Boys could face higher risks from COVID, even before birth.
Males are generally more vulnerable than females as fetuses and newborns; they’re more likely to be born prematurely and to die as infants. Preterm boys also have a higher risk of disability and death.
But coronavirus infection poses special dangers, said Sabra Klein, PhD, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, Baltimore.
That’s because boys are disproportionately affected by conditions linked to maternal infections. Boys are four times as likely as girls to be diagnosed with autism or attention-deficit/hyperactivity disorder, for example, while men are 75% more likely than women to develop schizophrenia.
Scientists don’t fully understand why boys appear more fragile in the womb, although testosterone – which can dampen immune response – may play a role, said Kristina Adams Waldorf, MD, a professor of obstetrics and gynecology at the University of Washington.
Men generally mount weaker immune responses than women and more often develop severe COVID infections. Recent research suggests boys with COVID are more likely than girls to become seriously ill or develop a rare inflammatory condition called multisystem inflammatory syndrome.
New research on COVID could help illuminate this vulnerability.
In a study published in October, researchers found that the sex of a fetus influences the way its placenta responds to COVID, as well as how its mother’s immune system responds.
Pregnant people infected with COVID made fewer antibodies against the coronavirus if they were carrying male fetuses than if they were carrying females. Mothers also transferred fewer antibodies to boys than to girls, said Andrea Edlow, MD, senior author of the study and a maternal-fetal medicine specialist at Massachusetts General Hospital, Boston.
When examining the placentas of male fetuses after delivery, researchers found changes that could leave boys less protected against damaging inflammation.
The sex of a fetus can influence its mother’s response to other illnesses, as well.
For example, research shows that pregnant women with asthma have worse symptoms if they’re carrying a female. Women carrying males are slightly more likely to develop gestational diabetes.
Dr. Edlow said her findings raise questions about the “cross talk” between mother and baby. “The mom’s immune system is sensing there is a male fetus,” Dr. Edlow said. “And the fetus is actively communicating with the mom’s immune system.”
Boosting toxic stress
Rates of depression and stress among pregnant women have increased dramatically during the pandemic.
That’s concerning because chronic stress can lead to inflammation, affecting the babies of both infected and uninfected women, Dr. Anagnostou said.
Studies consistently show that infants born to mothers who experience significant stress during pregnancy have higher rates of short- and long-term health damage – including heart defects and obesity – than babies born to women with less stress.
“We know that inflammation directly influences the way a baby’s brain develops,” said Elinor Sullivan, PhD, an associate professor in psychiatry at Oregon Health & Science University, Portland.
Lockdowns, travel restrictions and physical distancing left many pregnant women without the support of family and friends. The stress of losing a loved one, a job, or a home further heightens the risks to moms and babies, said Dr. Sullivan, who is following children born during the pandemic for 5 years.
In research that has not yet been published, Dr. Sullivan found that babies of women who were pregnant during the pandemic showed more sadness and negative emotions in the first year of life, compared with infants of women who were pregnant before the pandemic.
The findings show the importance of helping and protecting pregnant people before and after delivery, said Dr. Sullivan, who conducted a separate study that found women who received more social support were less depressed.
Italian researchers are also studying the effect of maternal stress on infants’ behavior, as well as the way their genes are regulated.
Although stress-related inflammation doesn’t alter the structure of a baby’s genes, it can influence whether they’re turned on and off, said Livio Provenzi, PhD, a psychologist at the C. Mondino National Institute of Neurology Foundation in Pavia, Italy.
In Dr. Provenzi’s study of 163 mother-baby pairs he found differences in how genes that regulate the stress response were activated. Genes that help people respond to stress were more likely to be turned off in babies whose moms reported the most stress during pregnancy. The same moms also reported that their babies cried more and were fussier when they were 3 months old.
Researchers usually prefer to make in-person observations of babies as they interact with their mothers, Dr. Provenzi said. But because of the pandemic, Dr. Provenzi asked mothers to fill out questionnaires about infant behavior. He plans to observe mothers and babies in person when the children are 12 months old.
While vaccinating pregnant people is the best way to protect them and their fetuses from the virus, Dr. Anagnostou said, society needs to do more to preserve expectant mothers’ mental health.
“We can’t escape the fact that we’ve lived through 2 years of a pandemic,” Dr. Anagnostou said. “But we can think about opportunities for reducing the risk.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
The pandemic has created a hostile environment for pregnant people and their babies.
Stress levels among expectant mothers have soared. Pregnant women with COVID are 5 times as likely as uninfected pregnant people to require intensive care and 22 times as likely to die. Infected moms are four times as likely to have a stillborn child.
Yet some of the pandemic’s greatest threats to infants’ health may not be apparent for years or even decades.
That’s because babies of COVID-infected moms are 60% more likely to be born very prematurely, which increases the danger of infant mortality and long-term disabilities such as cerebral palsy, asthma, and hearing loss, as well as a child’s risk of adult disease, including depression, anxiety, heart disease, and kidney disease.
Studies have linked fever and infection during pregnancy to developmental and psychiatric conditions such as autism, depression, and schizophrenia.
“Some of these conditions do not show up until middle childhood or early adult life, but they have their origins in fetal life,” said Evdokia Anagnostou, MD, a child neurologist at Holland Bloorview Kids Rehabilitation Hospital and a pediatrics professor at the University of Toronto.
For fetuses exposed to COVID, the greatest danger is usually not the coronavirus itself, but the mother’s immune system.
Both severe COVID infections and the strain of the pandemic can expose fetuses to harmful inflammation, which can occur when a mother’s immune system is fighting a virus or when stress hormones send nonstop alarm signals.
Prenatal inflammation “changes the way the brain develops and, depending on the timing of the infection, it can change the way the heart or kidneys develop,” Dr. Anagnostou said.
Although health officials have strongly recommended COVID vaccines for pregnant people, only 35% are fully vaccinated.
At least 150,000 pregnant women have been diagnosed with COVID; more than 25,000 of them have been hospitalized, and 249 have died, according to the Centers for Disease Control and Prevention.
Although most babies will be fine, even a small increase in the percentage of children with special medical or educational needs could have a large effect on the population, given the huge number of COVID infections, Dr. Anagnostou said.
“If someone has a baby who is doing well, that is what they should focus on,” Dr. Anagnostou said. “But from a public health point of view, we need to follow women who experienced severe COVID and their babies to understand the impact.”
Learning from history
Researchers in the United States and other countries are already studying “the COVID generation” to see whether these children have more health issues than those conceived or born before 2020.
Previous crises have shown that the challenges fetuses face in the womb – such as maternal infections, hunger, stress, and hormone-disrupting chemicals – can leave a lasting imprint on their health, as well as that of their children and grandchildren, said Frederick Kaskel, MD, director of pediatric nephrology at the Children’s Hospital at Montefiore, New York.
People whose mothers were pregnant during surges in the 1918 influenza pandemic, for example, had poorer health throughout their lives, compared with Americans born at other times, said John McCarthy, who is a medical student at Albert Einstein College of Medicine, New York, and cowrote a recent review in JAMA Pediatrics with Dr. Kaskel.
Researchers don’t know exactly which moms were infected with pandemic flu, Mr. McCarthy said. But women who were pregnant during major surges – when infection was widespread – had children with higher rates of heart disease or diabetes. These children were also less successful in school, less economically productive, and more likely to live with a disability.
Because organ systems develop during different periods of pregnancy, fetuses exposed during the first trimester may face different risks than those exposed toward the end of pregnancy, Mr. McCarthy said. For example, people born in the fall of 1918 were 50% more likely than others to develop kidney disease; that may reflect an exposure to the pandemic in the third trimester, while the kidneys were still developing.
Nearly 2 years into the COVID pandemic, researchers have begun to publish preliminary observations of infants exposed to COVID infections and stress before birth.
Although Dr. Anagnostou noted that it’s too early to reach definitive conclusions, “there is evidence that babies born to moms with severe COVID infections have changes to their immune system,” she said. “It’s enough to make us worry a little bit.”
Damaging a fetal security system
The good news about the coronavirus is that it seldom crosses the placenta, the organ tasked with protecting a developing fetus from infections and providing it with oxygen. So moms with COVID rarely give the virus to their children before birth.
That’s important, because some viruses that directly infect the fetus – such as Zika – can cause devastating birth defects, said Karin Nielsen-Saines, MD, a specialist in pediatric infectious diseases at University of California, Los Angeles.
But studies also suggest that inflammation from a mother’s COVID infection can injure the placenta, said Jeffery Goldstein, MD, an assistant professor of pathology at Northwestern University, Chicago. In a study published in American Journal of Clinical Pathology , Dr. Goldstein and his coauthors found that placentas from COVID-infected moms had more abnormal blood vessels than placentas from patients without COVID, making it harder for them to deliver sufficient oxygen to the fetus.
Placental damage can also lead to preeclampsia, a serious complication of pregnancy that can cause a mother’s blood pressure to spike.
Preeclampsia occurs when blood vessels in the placenta don’t develop or function properly, forcing the mother’s heart to work harder to get blood to the fetus, which may not receive enough oxygen and nutrients. Preeclampsia also predisposes women to heart attacks and strokes later in life.
Rewiring the immune system
In some cases, COVID also appears to rewire a baby’s immune response, Dr. Nielsen-Saines said.
In an October study in the journal Cell Reports Medicine, Dr. Nielsen-Saines and her coauthors found that infants born to people with severe COVID infections had a different mix of immune cells and proteins than other babies. None of the newborns tested positive for the coronavirus.
The immune changes are concerning, Dr. Nielsen-Saines said, because this pattern of immune cells and proteins has previously been found in infants with respiratory problems and in some cases poor neurodevelopment.
Notably, all the babies in her study appear healthy, said Dr. Nielsen-Saines, who plans to follow them for 3 years to see whether these early signals translate into developmental delays, such as problems talking, walking, or interacting with others.
“How big of a difference does any of this make in the baby?” asked Dr. Anagnostou. “We won’t know for a few years. All we can do is try to be as prepared as possible.”
Increasing the risk for boys
Boys could face higher risks from COVID, even before birth.
Males are generally more vulnerable than females as fetuses and newborns; they’re more likely to be born prematurely and to die as infants. Preterm boys also have a higher risk of disability and death.
But coronavirus infection poses special dangers, said Sabra Klein, PhD, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, Baltimore.
That’s because boys are disproportionately affected by conditions linked to maternal infections. Boys are four times as likely as girls to be diagnosed with autism or attention-deficit/hyperactivity disorder, for example, while men are 75% more likely than women to develop schizophrenia.
Scientists don’t fully understand why boys appear more fragile in the womb, although testosterone – which can dampen immune response – may play a role, said Kristina Adams Waldorf, MD, a professor of obstetrics and gynecology at the University of Washington.
Men generally mount weaker immune responses than women and more often develop severe COVID infections. Recent research suggests boys with COVID are more likely than girls to become seriously ill or develop a rare inflammatory condition called multisystem inflammatory syndrome.
New research on COVID could help illuminate this vulnerability.
In a study published in October, researchers found that the sex of a fetus influences the way its placenta responds to COVID, as well as how its mother’s immune system responds.
Pregnant people infected with COVID made fewer antibodies against the coronavirus if they were carrying male fetuses than if they were carrying females. Mothers also transferred fewer antibodies to boys than to girls, said Andrea Edlow, MD, senior author of the study and a maternal-fetal medicine specialist at Massachusetts General Hospital, Boston.
When examining the placentas of male fetuses after delivery, researchers found changes that could leave boys less protected against damaging inflammation.
The sex of a fetus can influence its mother’s response to other illnesses, as well.
For example, research shows that pregnant women with asthma have worse symptoms if they’re carrying a female. Women carrying males are slightly more likely to develop gestational diabetes.
Dr. Edlow said her findings raise questions about the “cross talk” between mother and baby. “The mom’s immune system is sensing there is a male fetus,” Dr. Edlow said. “And the fetus is actively communicating with the mom’s immune system.”
Boosting toxic stress
Rates of depression and stress among pregnant women have increased dramatically during the pandemic.
That’s concerning because chronic stress can lead to inflammation, affecting the babies of both infected and uninfected women, Dr. Anagnostou said.
Studies consistently show that infants born to mothers who experience significant stress during pregnancy have higher rates of short- and long-term health damage – including heart defects and obesity – than babies born to women with less stress.
“We know that inflammation directly influences the way a baby’s brain develops,” said Elinor Sullivan, PhD, an associate professor in psychiatry at Oregon Health & Science University, Portland.
Lockdowns, travel restrictions and physical distancing left many pregnant women without the support of family and friends. The stress of losing a loved one, a job, or a home further heightens the risks to moms and babies, said Dr. Sullivan, who is following children born during the pandemic for 5 years.
In research that has not yet been published, Dr. Sullivan found that babies of women who were pregnant during the pandemic showed more sadness and negative emotions in the first year of life, compared with infants of women who were pregnant before the pandemic.
The findings show the importance of helping and protecting pregnant people before and after delivery, said Dr. Sullivan, who conducted a separate study that found women who received more social support were less depressed.
Italian researchers are also studying the effect of maternal stress on infants’ behavior, as well as the way their genes are regulated.
Although stress-related inflammation doesn’t alter the structure of a baby’s genes, it can influence whether they’re turned on and off, said Livio Provenzi, PhD, a psychologist at the C. Mondino National Institute of Neurology Foundation in Pavia, Italy.
In Dr. Provenzi’s study of 163 mother-baby pairs he found differences in how genes that regulate the stress response were activated. Genes that help people respond to stress were more likely to be turned off in babies whose moms reported the most stress during pregnancy. The same moms also reported that their babies cried more and were fussier when they were 3 months old.
Researchers usually prefer to make in-person observations of babies as they interact with their mothers, Dr. Provenzi said. But because of the pandemic, Dr. Provenzi asked mothers to fill out questionnaires about infant behavior. He plans to observe mothers and babies in person when the children are 12 months old.
While vaccinating pregnant people is the best way to protect them and their fetuses from the virus, Dr. Anagnostou said, society needs to do more to preserve expectant mothers’ mental health.
“We can’t escape the fact that we’ve lived through 2 years of a pandemic,” Dr. Anagnostou said. “But we can think about opportunities for reducing the risk.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
The pandemic has created a hostile environment for pregnant people and their babies.
Stress levels among expectant mothers have soared. Pregnant women with COVID are 5 times as likely as uninfected pregnant people to require intensive care and 22 times as likely to die. Infected moms are four times as likely to have a stillborn child.
Yet some of the pandemic’s greatest threats to infants’ health may not be apparent for years or even decades.
That’s because babies of COVID-infected moms are 60% more likely to be born very prematurely, which increases the danger of infant mortality and long-term disabilities such as cerebral palsy, asthma, and hearing loss, as well as a child’s risk of adult disease, including depression, anxiety, heart disease, and kidney disease.
Studies have linked fever and infection during pregnancy to developmental and psychiatric conditions such as autism, depression, and schizophrenia.
“Some of these conditions do not show up until middle childhood or early adult life, but they have their origins in fetal life,” said Evdokia Anagnostou, MD, a child neurologist at Holland Bloorview Kids Rehabilitation Hospital and a pediatrics professor at the University of Toronto.
For fetuses exposed to COVID, the greatest danger is usually not the coronavirus itself, but the mother’s immune system.
Both severe COVID infections and the strain of the pandemic can expose fetuses to harmful inflammation, which can occur when a mother’s immune system is fighting a virus or when stress hormones send nonstop alarm signals.
Prenatal inflammation “changes the way the brain develops and, depending on the timing of the infection, it can change the way the heart or kidneys develop,” Dr. Anagnostou said.
Although health officials have strongly recommended COVID vaccines for pregnant people, only 35% are fully vaccinated.
At least 150,000 pregnant women have been diagnosed with COVID; more than 25,000 of them have been hospitalized, and 249 have died, according to the Centers for Disease Control and Prevention.
Although most babies will be fine, even a small increase in the percentage of children with special medical or educational needs could have a large effect on the population, given the huge number of COVID infections, Dr. Anagnostou said.
“If someone has a baby who is doing well, that is what they should focus on,” Dr. Anagnostou said. “But from a public health point of view, we need to follow women who experienced severe COVID and their babies to understand the impact.”
Learning from history
Researchers in the United States and other countries are already studying “the COVID generation” to see whether these children have more health issues than those conceived or born before 2020.
Previous crises have shown that the challenges fetuses face in the womb – such as maternal infections, hunger, stress, and hormone-disrupting chemicals – can leave a lasting imprint on their health, as well as that of their children and grandchildren, said Frederick Kaskel, MD, director of pediatric nephrology at the Children’s Hospital at Montefiore, New York.
People whose mothers were pregnant during surges in the 1918 influenza pandemic, for example, had poorer health throughout their lives, compared with Americans born at other times, said John McCarthy, who is a medical student at Albert Einstein College of Medicine, New York, and cowrote a recent review in JAMA Pediatrics with Dr. Kaskel.
Researchers don’t know exactly which moms were infected with pandemic flu, Mr. McCarthy said. But women who were pregnant during major surges – when infection was widespread – had children with higher rates of heart disease or diabetes. These children were also less successful in school, less economically productive, and more likely to live with a disability.
Because organ systems develop during different periods of pregnancy, fetuses exposed during the first trimester may face different risks than those exposed toward the end of pregnancy, Mr. McCarthy said. For example, people born in the fall of 1918 were 50% more likely than others to develop kidney disease; that may reflect an exposure to the pandemic in the third trimester, while the kidneys were still developing.
Nearly 2 years into the COVID pandemic, researchers have begun to publish preliminary observations of infants exposed to COVID infections and stress before birth.
Although Dr. Anagnostou noted that it’s too early to reach definitive conclusions, “there is evidence that babies born to moms with severe COVID infections have changes to their immune system,” she said. “It’s enough to make us worry a little bit.”
Damaging a fetal security system
The good news about the coronavirus is that it seldom crosses the placenta, the organ tasked with protecting a developing fetus from infections and providing it with oxygen. So moms with COVID rarely give the virus to their children before birth.
That’s important, because some viruses that directly infect the fetus – such as Zika – can cause devastating birth defects, said Karin Nielsen-Saines, MD, a specialist in pediatric infectious diseases at University of California, Los Angeles.
But studies also suggest that inflammation from a mother’s COVID infection can injure the placenta, said Jeffery Goldstein, MD, an assistant professor of pathology at Northwestern University, Chicago. In a study published in American Journal of Clinical Pathology , Dr. Goldstein and his coauthors found that placentas from COVID-infected moms had more abnormal blood vessels than placentas from patients without COVID, making it harder for them to deliver sufficient oxygen to the fetus.
Placental damage can also lead to preeclampsia, a serious complication of pregnancy that can cause a mother’s blood pressure to spike.
Preeclampsia occurs when blood vessels in the placenta don’t develop or function properly, forcing the mother’s heart to work harder to get blood to the fetus, which may not receive enough oxygen and nutrients. Preeclampsia also predisposes women to heart attacks and strokes later in life.
Rewiring the immune system
In some cases, COVID also appears to rewire a baby’s immune response, Dr. Nielsen-Saines said.
In an October study in the journal Cell Reports Medicine, Dr. Nielsen-Saines and her coauthors found that infants born to people with severe COVID infections had a different mix of immune cells and proteins than other babies. None of the newborns tested positive for the coronavirus.
The immune changes are concerning, Dr. Nielsen-Saines said, because this pattern of immune cells and proteins has previously been found in infants with respiratory problems and in some cases poor neurodevelopment.
Notably, all the babies in her study appear healthy, said Dr. Nielsen-Saines, who plans to follow them for 3 years to see whether these early signals translate into developmental delays, such as problems talking, walking, or interacting with others.
“How big of a difference does any of this make in the baby?” asked Dr. Anagnostou. “We won’t know for a few years. All we can do is try to be as prepared as possible.”
Increasing the risk for boys
Boys could face higher risks from COVID, even before birth.
Males are generally more vulnerable than females as fetuses and newborns; they’re more likely to be born prematurely and to die as infants. Preterm boys also have a higher risk of disability and death.
But coronavirus infection poses special dangers, said Sabra Klein, PhD, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, Baltimore.
That’s because boys are disproportionately affected by conditions linked to maternal infections. Boys are four times as likely as girls to be diagnosed with autism or attention-deficit/hyperactivity disorder, for example, while men are 75% more likely than women to develop schizophrenia.
Scientists don’t fully understand why boys appear more fragile in the womb, although testosterone – which can dampen immune response – may play a role, said Kristina Adams Waldorf, MD, a professor of obstetrics and gynecology at the University of Washington.
Men generally mount weaker immune responses than women and more often develop severe COVID infections. Recent research suggests boys with COVID are more likely than girls to become seriously ill or develop a rare inflammatory condition called multisystem inflammatory syndrome.
New research on COVID could help illuminate this vulnerability.
In a study published in October, researchers found that the sex of a fetus influences the way its placenta responds to COVID, as well as how its mother’s immune system responds.
Pregnant people infected with COVID made fewer antibodies against the coronavirus if they were carrying male fetuses than if they were carrying females. Mothers also transferred fewer antibodies to boys than to girls, said Andrea Edlow, MD, senior author of the study and a maternal-fetal medicine specialist at Massachusetts General Hospital, Boston.
When examining the placentas of male fetuses after delivery, researchers found changes that could leave boys less protected against damaging inflammation.
The sex of a fetus can influence its mother’s response to other illnesses, as well.
For example, research shows that pregnant women with asthma have worse symptoms if they’re carrying a female. Women carrying males are slightly more likely to develop gestational diabetes.
Dr. Edlow said her findings raise questions about the “cross talk” between mother and baby. “The mom’s immune system is sensing there is a male fetus,” Dr. Edlow said. “And the fetus is actively communicating with the mom’s immune system.”
Boosting toxic stress
Rates of depression and stress among pregnant women have increased dramatically during the pandemic.
That’s concerning because chronic stress can lead to inflammation, affecting the babies of both infected and uninfected women, Dr. Anagnostou said.
Studies consistently show that infants born to mothers who experience significant stress during pregnancy have higher rates of short- and long-term health damage – including heart defects and obesity – than babies born to women with less stress.
“We know that inflammation directly influences the way a baby’s brain develops,” said Elinor Sullivan, PhD, an associate professor in psychiatry at Oregon Health & Science University, Portland.
Lockdowns, travel restrictions and physical distancing left many pregnant women without the support of family and friends. The stress of losing a loved one, a job, or a home further heightens the risks to moms and babies, said Dr. Sullivan, who is following children born during the pandemic for 5 years.
In research that has not yet been published, Dr. Sullivan found that babies of women who were pregnant during the pandemic showed more sadness and negative emotions in the first year of life, compared with infants of women who were pregnant before the pandemic.
The findings show the importance of helping and protecting pregnant people before and after delivery, said Dr. Sullivan, who conducted a separate study that found women who received more social support were less depressed.
Italian researchers are also studying the effect of maternal stress on infants’ behavior, as well as the way their genes are regulated.
Although stress-related inflammation doesn’t alter the structure of a baby’s genes, it can influence whether they’re turned on and off, said Livio Provenzi, PhD, a psychologist at the C. Mondino National Institute of Neurology Foundation in Pavia, Italy.
In Dr. Provenzi’s study of 163 mother-baby pairs he found differences in how genes that regulate the stress response were activated. Genes that help people respond to stress were more likely to be turned off in babies whose moms reported the most stress during pregnancy. The same moms also reported that their babies cried more and were fussier when they were 3 months old.
Researchers usually prefer to make in-person observations of babies as they interact with their mothers, Dr. Provenzi said. But because of the pandemic, Dr. Provenzi asked mothers to fill out questionnaires about infant behavior. He plans to observe mothers and babies in person when the children are 12 months old.
While vaccinating pregnant people is the best way to protect them and their fetuses from the virus, Dr. Anagnostou said, society needs to do more to preserve expectant mothers’ mental health.
“We can’t escape the fact that we’ve lived through 2 years of a pandemic,” Dr. Anagnostou said. “But we can think about opportunities for reducing the risk.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
‘I Can Go Anywhere’: How Service Dogs Help Veterans With PTSD
It was supper time in the Whittier, California, home of Air Force veteran Danyelle Clark-Gutierrez, and eagerly awaiting a bowl of kibble and canned dog food was Lisa, a 3-year-old yellow Labrador retriever.
Her nails clicking on the kitchen floor as she danced about, Lisa looked more like an exuberant puppy than the highly trained service animal that helps Clark-Gutierrez manage the symptoms of post-traumatic stress disorder.
“Having her now, it’s like I can go anywhere,” Clark-Gutierrez said. “And, yes, if somebody did come at me, I’d have warning — I could run.”
A growing body of research into PTSD and service animals paved the way for President Joe Biden to sign into law the Puppies Assisting Wounded Servicemembers (PAWS) for Veterans Therapy Act. The legislation, enacted in August, requires the Department of Veterans Affairs to open its service dog referral program to veterans with PTSD and to launch a five-year pilot program in which veterans with PTSD train service dogs for other veterans.
Clark-Gutierrez, 33, is among the 25 percent of female veterans who have reported experiencing military sexual trauma while serving in the U.S. armed services.
Military sexual trauma, combat violence and brain injuries are some of the experiences that increase the risk that service members will develop PTSD. Symptoms include flashbacks to the traumatic event, severe anxiety, nightmares and hypervigilance — all normal reactions to experiencing or witnessing violence, according to psychologists. Someone receives a PTSD diagnosis when symptoms worsen or remain for months or years.
That’s what Clark-Gutierrez said happened to her after ongoing sexual harassment by a fellow airman escalated to a physical attack about a decade ago. A lawyer with three children, she said that to feel safe leaving her home she needed her husband by her side. After diagnosing Clark-Gutierrez with PTSD, doctors at VA hospitals prescribed a cascade of medications for her. At one point, Clark-Gutierrez said, her prescriptions added up to more than a dozen pills a day.
“I had medication, and then I had medication for the two or three side effects for each medication,” she said. “And every time they gave me a new med, they had to give me three more. I just couldn’t do it anymore. I was just getting so tired. So we started looking at other therapies.”
And that’s how she got her service dog, Lisa. Clark-Gutierrez’s husband, also an Air Force veteran, discovered the nonprofit group K9s for Warriors, which rescues dogs — many from kill shelters — and trains them to be service animals for veterans with PTSD. Lisa is one of about 700 dogs the group has paired with veterans dealing with symptoms caused by traumatic experiences.
“Now with Lisa we take bike rides, we go down to the park, we go to Home Depot,” said Clark-Gutierrez. “I go grocery shopping — normal-people things that I get to do that I didn’t get to do before Lisa.”
That comes as no surprise to Maggie O’Haire, an associate professor of human-animal interaction at Purdue University. Her research suggests that while service dogs aren’t necessarily a cure for PTSD, they do ease its symptoms. Among her published studies is one showing that veterans partnered with these dogs experience less anger and anxiety and get better sleep than those without a service dog. Another of her studies suggests that service dogs lower cortisol levels in veterans who have been traumatized.
“We actually saw patterns of that stress hormone that were more similar to healthy adults who don’t have post-traumatic stress disorder,” O’Haire said.
A congressionally mandated VA study that focuses on service dogs’ impact on veterans with PTSD and was published this year suggests that those partnered with the animals experience less suicidal ideation and more improvement to their symptoms than those without them.
Until now, the federal dog referral program — which relies on nonprofit service dog organizations to pay for the dogs and to provide them to veterans for free — required that participating veterans have a physical mobility issue, such as a lost limb, paralysis or blindness. Veterans like Clark-Gutierrez who have PTSD but no physical disability were on their own in arranging for a service dog.
The pilot program created by the new federal law will give veterans with PTSD the chance to train mental health service dogs for other veterans. It’s modeled on a program at the VA hospital in Palo Alto, California, and will be offered at five VA medical centers nationwide in partnership with accredited service dog training organizations.
“This bill is really about therapeutic, on-the-job training, or ‘training the trainer,’” said Adam Webb, a spokesperson for Sen. Thom Tillis (R-N.C.), who introduced the legislation in the Senate. “We don’t anticipate VA will start prescribing PTSD service dogs, but the data we generate from this pilot program will likely be useful in making that case in the future.”
The Congressional Budget Office estimates the pilot program will cost the VA about $19 million. The law stops short of requiring the VA to pay for the dogs. Instead, the agency will partner with accredited service dog organizations that use private money to cover the cost of adopting, training and pairing the dogs with veterans.
Still, the law represents a welcome about-face in VA policy, said Rory Diamond, CEO of K9s for Warriors.
“For the last 10 years, the VA has essentially told us that they don’t recognize service dogs as helping a veteran with post-traumatic stress,” Diamond said.
PTSD service dogs are often confused with emotional support dogs, Diamond said. The latter provide companionship and are not trained to support someone with a disability. PTSD service dogs cost about $25,000 to adopt and train, he said.
Diamond explained that the command “cover” means “the dog will sit next to the warrior, look behind them and alert them if someone comes up from behind.” The command “block” means the dog will “stand perpendicular and give them some space from whatever’s in front of them.”
Retired Army Master Sgt. David Crenshaw of Kearny, New Jersey, said his service dog, Doc, has changed his life.
“We teach in the military to have a battle buddy,” Crenshaw said. “And these service animals act as a battle buddy.”
A few months ago, Crenshaw experienced this firsthand. He had generally avoided large gatherings because persistent hypervigilance is one symptom of his combat-caused PTSD. But this summer, Doc, a pointer and Labrador mix, helped Crenshaw navigate the crowds at Disney World — a significant first for Crenshaw and his family of five.
“I was not agitated. I was not anxious. I was not upset,” said Crenshaw, 39. “It was truly, truly amazing and so much so that I didn’t even have to even stop to think about it in the moment. It just happened naturally.”
Thanks to Doc, Crenshaw said, he no longer takes PTSD drugs or self-medicates with alcohol. Clark-Gutierrez said Lisa, too, has helped her quit using alcohol and stop taking VA-prescribed medications for panic attacks, nightmares and periods of disassociation.
The dogs actually save the VA money over time, Diamond said. “Our warriors are far less likely to be on expensive prescription drugs, are far less likely to use other VA services and far more likely to go to school or go to work. So it’s a win-win-win across the board.”
It was supper time in the Whittier, California, home of Air Force veteran Danyelle Clark-Gutierrez, and eagerly awaiting a bowl of kibble and canned dog food was Lisa, a 3-year-old yellow Labrador retriever.
Her nails clicking on the kitchen floor as she danced about, Lisa looked more like an exuberant puppy than the highly trained service animal that helps Clark-Gutierrez manage the symptoms of post-traumatic stress disorder.
“Having her now, it’s like I can go anywhere,” Clark-Gutierrez said. “And, yes, if somebody did come at me, I’d have warning — I could run.”
A growing body of research into PTSD and service animals paved the way for President Joe Biden to sign into law the Puppies Assisting Wounded Servicemembers (PAWS) for Veterans Therapy Act. The legislation, enacted in August, requires the Department of Veterans Affairs to open its service dog referral program to veterans with PTSD and to launch a five-year pilot program in which veterans with PTSD train service dogs for other veterans.
Clark-Gutierrez, 33, is among the 25 percent of female veterans who have reported experiencing military sexual trauma while serving in the U.S. armed services.
Military sexual trauma, combat violence and brain injuries are some of the experiences that increase the risk that service members will develop PTSD. Symptoms include flashbacks to the traumatic event, severe anxiety, nightmares and hypervigilance — all normal reactions to experiencing or witnessing violence, according to psychologists. Someone receives a PTSD diagnosis when symptoms worsen or remain for months or years.
That’s what Clark-Gutierrez said happened to her after ongoing sexual harassment by a fellow airman escalated to a physical attack about a decade ago. A lawyer with three children, she said that to feel safe leaving her home she needed her husband by her side. After diagnosing Clark-Gutierrez with PTSD, doctors at VA hospitals prescribed a cascade of medications for her. At one point, Clark-Gutierrez said, her prescriptions added up to more than a dozen pills a day.
“I had medication, and then I had medication for the two or three side effects for each medication,” she said. “And every time they gave me a new med, they had to give me three more. I just couldn’t do it anymore. I was just getting so tired. So we started looking at other therapies.”
And that’s how she got her service dog, Lisa. Clark-Gutierrez’s husband, also an Air Force veteran, discovered the nonprofit group K9s for Warriors, which rescues dogs — many from kill shelters — and trains them to be service animals for veterans with PTSD. Lisa is one of about 700 dogs the group has paired with veterans dealing with symptoms caused by traumatic experiences.
“Now with Lisa we take bike rides, we go down to the park, we go to Home Depot,” said Clark-Gutierrez. “I go grocery shopping — normal-people things that I get to do that I didn’t get to do before Lisa.”
That comes as no surprise to Maggie O’Haire, an associate professor of human-animal interaction at Purdue University. Her research suggests that while service dogs aren’t necessarily a cure for PTSD, they do ease its symptoms. Among her published studies is one showing that veterans partnered with these dogs experience less anger and anxiety and get better sleep than those without a service dog. Another of her studies suggests that service dogs lower cortisol levels in veterans who have been traumatized.
“We actually saw patterns of that stress hormone that were more similar to healthy adults who don’t have post-traumatic stress disorder,” O’Haire said.
A congressionally mandated VA study that focuses on service dogs’ impact on veterans with PTSD and was published this year suggests that those partnered with the animals experience less suicidal ideation and more improvement to their symptoms than those without them.
Until now, the federal dog referral program — which relies on nonprofit service dog organizations to pay for the dogs and to provide them to veterans for free — required that participating veterans have a physical mobility issue, such as a lost limb, paralysis or blindness. Veterans like Clark-Gutierrez who have PTSD but no physical disability were on their own in arranging for a service dog.
The pilot program created by the new federal law will give veterans with PTSD the chance to train mental health service dogs for other veterans. It’s modeled on a program at the VA hospital in Palo Alto, California, and will be offered at five VA medical centers nationwide in partnership with accredited service dog training organizations.
“This bill is really about therapeutic, on-the-job training, or ‘training the trainer,’” said Adam Webb, a spokesperson for Sen. Thom Tillis (R-N.C.), who introduced the legislation in the Senate. “We don’t anticipate VA will start prescribing PTSD service dogs, but the data we generate from this pilot program will likely be useful in making that case in the future.”
The Congressional Budget Office estimates the pilot program will cost the VA about $19 million. The law stops short of requiring the VA to pay for the dogs. Instead, the agency will partner with accredited service dog organizations that use private money to cover the cost of adopting, training and pairing the dogs with veterans.
Still, the law represents a welcome about-face in VA policy, said Rory Diamond, CEO of K9s for Warriors.
“For the last 10 years, the VA has essentially told us that they don’t recognize service dogs as helping a veteran with post-traumatic stress,” Diamond said.
PTSD service dogs are often confused with emotional support dogs, Diamond said. The latter provide companionship and are not trained to support someone with a disability. PTSD service dogs cost about $25,000 to adopt and train, he said.
Diamond explained that the command “cover” means “the dog will sit next to the warrior, look behind them and alert them if someone comes up from behind.” The command “block” means the dog will “stand perpendicular and give them some space from whatever’s in front of them.”
Retired Army Master Sgt. David Crenshaw of Kearny, New Jersey, said his service dog, Doc, has changed his life.
“We teach in the military to have a battle buddy,” Crenshaw said. “And these service animals act as a battle buddy.”
A few months ago, Crenshaw experienced this firsthand. He had generally avoided large gatherings because persistent hypervigilance is one symptom of his combat-caused PTSD. But this summer, Doc, a pointer and Labrador mix, helped Crenshaw navigate the crowds at Disney World — a significant first for Crenshaw and his family of five.
“I was not agitated. I was not anxious. I was not upset,” said Crenshaw, 39. “It was truly, truly amazing and so much so that I didn’t even have to even stop to think about it in the moment. It just happened naturally.”
Thanks to Doc, Crenshaw said, he no longer takes PTSD drugs or self-medicates with alcohol. Clark-Gutierrez said Lisa, too, has helped her quit using alcohol and stop taking VA-prescribed medications for panic attacks, nightmares and periods of disassociation.
The dogs actually save the VA money over time, Diamond said. “Our warriors are far less likely to be on expensive prescription drugs, are far less likely to use other VA services and far more likely to go to school or go to work. So it’s a win-win-win across the board.”
It was supper time in the Whittier, California, home of Air Force veteran Danyelle Clark-Gutierrez, and eagerly awaiting a bowl of kibble and canned dog food was Lisa, a 3-year-old yellow Labrador retriever.
Her nails clicking on the kitchen floor as she danced about, Lisa looked more like an exuberant puppy than the highly trained service animal that helps Clark-Gutierrez manage the symptoms of post-traumatic stress disorder.
“Having her now, it’s like I can go anywhere,” Clark-Gutierrez said. “And, yes, if somebody did come at me, I’d have warning — I could run.”
A growing body of research into PTSD and service animals paved the way for President Joe Biden to sign into law the Puppies Assisting Wounded Servicemembers (PAWS) for Veterans Therapy Act. The legislation, enacted in August, requires the Department of Veterans Affairs to open its service dog referral program to veterans with PTSD and to launch a five-year pilot program in which veterans with PTSD train service dogs for other veterans.
Clark-Gutierrez, 33, is among the 25 percent of female veterans who have reported experiencing military sexual trauma while serving in the U.S. armed services.
Military sexual trauma, combat violence and brain injuries are some of the experiences that increase the risk that service members will develop PTSD. Symptoms include flashbacks to the traumatic event, severe anxiety, nightmares and hypervigilance — all normal reactions to experiencing or witnessing violence, according to psychologists. Someone receives a PTSD diagnosis when symptoms worsen or remain for months or years.
That’s what Clark-Gutierrez said happened to her after ongoing sexual harassment by a fellow airman escalated to a physical attack about a decade ago. A lawyer with three children, she said that to feel safe leaving her home she needed her husband by her side. After diagnosing Clark-Gutierrez with PTSD, doctors at VA hospitals prescribed a cascade of medications for her. At one point, Clark-Gutierrez said, her prescriptions added up to more than a dozen pills a day.
“I had medication, and then I had medication for the two or three side effects for each medication,” she said. “And every time they gave me a new med, they had to give me three more. I just couldn’t do it anymore. I was just getting so tired. So we started looking at other therapies.”
And that’s how she got her service dog, Lisa. Clark-Gutierrez’s husband, also an Air Force veteran, discovered the nonprofit group K9s for Warriors, which rescues dogs — many from kill shelters — and trains them to be service animals for veterans with PTSD. Lisa is one of about 700 dogs the group has paired with veterans dealing with symptoms caused by traumatic experiences.
“Now with Lisa we take bike rides, we go down to the park, we go to Home Depot,” said Clark-Gutierrez. “I go grocery shopping — normal-people things that I get to do that I didn’t get to do before Lisa.”
That comes as no surprise to Maggie O’Haire, an associate professor of human-animal interaction at Purdue University. Her research suggests that while service dogs aren’t necessarily a cure for PTSD, they do ease its symptoms. Among her published studies is one showing that veterans partnered with these dogs experience less anger and anxiety and get better sleep than those without a service dog. Another of her studies suggests that service dogs lower cortisol levels in veterans who have been traumatized.
“We actually saw patterns of that stress hormone that were more similar to healthy adults who don’t have post-traumatic stress disorder,” O’Haire said.
A congressionally mandated VA study that focuses on service dogs’ impact on veterans with PTSD and was published this year suggests that those partnered with the animals experience less suicidal ideation and more improvement to their symptoms than those without them.
Until now, the federal dog referral program — which relies on nonprofit service dog organizations to pay for the dogs and to provide them to veterans for free — required that participating veterans have a physical mobility issue, such as a lost limb, paralysis or blindness. Veterans like Clark-Gutierrez who have PTSD but no physical disability were on their own in arranging for a service dog.
The pilot program created by the new federal law will give veterans with PTSD the chance to train mental health service dogs for other veterans. It’s modeled on a program at the VA hospital in Palo Alto, California, and will be offered at five VA medical centers nationwide in partnership with accredited service dog training organizations.
“This bill is really about therapeutic, on-the-job training, or ‘training the trainer,’” said Adam Webb, a spokesperson for Sen. Thom Tillis (R-N.C.), who introduced the legislation in the Senate. “We don’t anticipate VA will start prescribing PTSD service dogs, but the data we generate from this pilot program will likely be useful in making that case in the future.”
The Congressional Budget Office estimates the pilot program will cost the VA about $19 million. The law stops short of requiring the VA to pay for the dogs. Instead, the agency will partner with accredited service dog organizations that use private money to cover the cost of adopting, training and pairing the dogs with veterans.
Still, the law represents a welcome about-face in VA policy, said Rory Diamond, CEO of K9s for Warriors.
“For the last 10 years, the VA has essentially told us that they don’t recognize service dogs as helping a veteran with post-traumatic stress,” Diamond said.
PTSD service dogs are often confused with emotional support dogs, Diamond said. The latter provide companionship and are not trained to support someone with a disability. PTSD service dogs cost about $25,000 to adopt and train, he said.
Diamond explained that the command “cover” means “the dog will sit next to the warrior, look behind them and alert them if someone comes up from behind.” The command “block” means the dog will “stand perpendicular and give them some space from whatever’s in front of them.”
Retired Army Master Sgt. David Crenshaw of Kearny, New Jersey, said his service dog, Doc, has changed his life.
“We teach in the military to have a battle buddy,” Crenshaw said. “And these service animals act as a battle buddy.”
A few months ago, Crenshaw experienced this firsthand. He had generally avoided large gatherings because persistent hypervigilance is one symptom of his combat-caused PTSD. But this summer, Doc, a pointer and Labrador mix, helped Crenshaw navigate the crowds at Disney World — a significant first for Crenshaw and his family of five.
“I was not agitated. I was not anxious. I was not upset,” said Crenshaw, 39. “It was truly, truly amazing and so much so that I didn’t even have to even stop to think about it in the moment. It just happened naturally.”
Thanks to Doc, Crenshaw said, he no longer takes PTSD drugs or self-medicates with alcohol. Clark-Gutierrez said Lisa, too, has helped her quit using alcohol and stop taking VA-prescribed medications for panic attacks, nightmares and periods of disassociation.
The dogs actually save the VA money over time, Diamond said. “Our warriors are far less likely to be on expensive prescription drugs, are far less likely to use other VA services and far more likely to go to school or go to work. So it’s a win-win-win across the board.”
Breaking a 10-year streak, the number of uninsured Americans rises
For the first time in a decade, the number of Americans without health insurance has risen – by about 2 million people in 2018 – according to the annual U.S. Census Bureau report released Sept. 10, 2019.
The Census found that 8.5% of the U.S. population went without medical insurance for all of 2018, up from 7.9% in 2017. By contrast, in 2013, before the Affordable Care Act took full effect, 13.3% were uninsured. It was the first year-to-year increase since 2008-09, Census officials said, adding that most of the drop in health coverage was related to a 0.7% decline in Medicaid participants. The number of people with private insurance remained steady and there was a 0.4% increase in those on Medicare.
Many of those losing coverage were noncitizens, a possible fallout from the Trump administration’s tough immigration policies and rhetoric. About 574,000 noncitizens lost coverage in 2018, a drop of about 2.3%, the report found.
“Uninsured noncitizens account for almost a third of the increase in uninsured, which may reflect the administration’s more aggressive stance on immigration,” said Joseph Antos, a health economist at the American Enterprise Institute.
The increase in the number of uninsured people in 2018 was remarkable because uninsured rates typically fall or hold steady when unemployment rates drop. The U.S. unemployment rate fell slightly from about 4.3% in 2017 to 4% in 2018.
The uninsured rate continued to vary by poverty status and whether a state expanded its Medicaid program under Obamacare. Texas (17.7%), Oklahoma (14.2%), Georgia (13.7%), and Florida (13%) had the highest uninsured rates in 2018, according to the report. None of those states have expanded Medicaid under Obamacare.
The percentage of uninsured children aged under 19 years increased by 0.6 percentage points from 2017 to 2018, to 5.5%.
“The Census data are clear – the uninsured rate for kids is up sharply and it’s due to a loss of public coverage – mostly Medicaid,” Joan Alker, executive director of Georgetown University Center for Children and Families, said in a statement.
“These children are not getting private coverage as the Trump administration has suggested but rather becoming uninsured,” she said. “This serious erosion of children’s health coverage is due in large part to the Trump administration’s actions that have made health care harder to access and have deterred families from enrolling their children.”
The share of Americans without medical insurance fell steadily since 2014 but then leveled off in 2017, the year Mr. Trump became president.
Health care advocates have complained that efforts by the Trump administration and Congress are jeopardizing insurance enrollment. They point to cuts in outreach programs that aim to tell consumers about their health care options under Obamacare and the elimination of the ACA’s tax penalty for people who don’t have health coverage.
Ms. Alker complained that the administration’s policies are causing the loss of children’s coverage. “In a period of continued economic and job growth, we shouldn’t be going backwards on health coverage,” said Judy Solomon, a senior fellow for the Center on Budget and Policy Priorities, a left-leaning think tank. “This backsliding almost certainly reflects, at least in part, Trump administration policies to weaken public health coverage.”
She attributed the drop to the Trump administration making it harder for families to enroll for coverage in Medicaid by curtailing outreach efforts, allowing states to ask for more paperwork and proposing a so-called public charge rule that would make it harder for legal immigrants to get permanent resident status if they have received certain kinds of public assistance – including Medicaid.
Tom Miller, a resident fellow at the American Enterprise Institute, a conservative think tank, said the drop in Medicaid coverage “is a positive.”
“When the economy grows Medicaid eventually drops,” he said.
One reason for the drop in health coverage is that middle-income families can’t afford the rising cost of insurance in the individual market, particularly if they don’t qualify for government subsidies, he added.
“On balance, this is some short-term noise,” he said of the uptick in the uninsured rate. “I would put more stake in it if happens for several years.”
Chris Pope, a senior fellow with the conservative Manhattan Institute, also said he considered the change “fairly small” and likely caused by increasing wages “pushing people above the income eligibility cutoff in Medicaid expansion states.”
But he suggested that next year would be a better indicator of how changes in the ACA are playing out. “I expect that the mandate repeal will make next year’s increase in the uninsured more significant.”
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.
For the first time in a decade, the number of Americans without health insurance has risen – by about 2 million people in 2018 – according to the annual U.S. Census Bureau report released Sept. 10, 2019.
The Census found that 8.5% of the U.S. population went without medical insurance for all of 2018, up from 7.9% in 2017. By contrast, in 2013, before the Affordable Care Act took full effect, 13.3% were uninsured. It was the first year-to-year increase since 2008-09, Census officials said, adding that most of the drop in health coverage was related to a 0.7% decline in Medicaid participants. The number of people with private insurance remained steady and there was a 0.4% increase in those on Medicare.
Many of those losing coverage were noncitizens, a possible fallout from the Trump administration’s tough immigration policies and rhetoric. About 574,000 noncitizens lost coverage in 2018, a drop of about 2.3%, the report found.
“Uninsured noncitizens account for almost a third of the increase in uninsured, which may reflect the administration’s more aggressive stance on immigration,” said Joseph Antos, a health economist at the American Enterprise Institute.
The increase in the number of uninsured people in 2018 was remarkable because uninsured rates typically fall or hold steady when unemployment rates drop. The U.S. unemployment rate fell slightly from about 4.3% in 2017 to 4% in 2018.
The uninsured rate continued to vary by poverty status and whether a state expanded its Medicaid program under Obamacare. Texas (17.7%), Oklahoma (14.2%), Georgia (13.7%), and Florida (13%) had the highest uninsured rates in 2018, according to the report. None of those states have expanded Medicaid under Obamacare.
The percentage of uninsured children aged under 19 years increased by 0.6 percentage points from 2017 to 2018, to 5.5%.
“The Census data are clear – the uninsured rate for kids is up sharply and it’s due to a loss of public coverage – mostly Medicaid,” Joan Alker, executive director of Georgetown University Center for Children and Families, said in a statement.
“These children are not getting private coverage as the Trump administration has suggested but rather becoming uninsured,” she said. “This serious erosion of children’s health coverage is due in large part to the Trump administration’s actions that have made health care harder to access and have deterred families from enrolling their children.”
The share of Americans without medical insurance fell steadily since 2014 but then leveled off in 2017, the year Mr. Trump became president.
Health care advocates have complained that efforts by the Trump administration and Congress are jeopardizing insurance enrollment. They point to cuts in outreach programs that aim to tell consumers about their health care options under Obamacare and the elimination of the ACA’s tax penalty for people who don’t have health coverage.
Ms. Alker complained that the administration’s policies are causing the loss of children’s coverage. “In a period of continued economic and job growth, we shouldn’t be going backwards on health coverage,” said Judy Solomon, a senior fellow for the Center on Budget and Policy Priorities, a left-leaning think tank. “This backsliding almost certainly reflects, at least in part, Trump administration policies to weaken public health coverage.”
She attributed the drop to the Trump administration making it harder for families to enroll for coverage in Medicaid by curtailing outreach efforts, allowing states to ask for more paperwork and proposing a so-called public charge rule that would make it harder for legal immigrants to get permanent resident status if they have received certain kinds of public assistance – including Medicaid.
Tom Miller, a resident fellow at the American Enterprise Institute, a conservative think tank, said the drop in Medicaid coverage “is a positive.”
“When the economy grows Medicaid eventually drops,” he said.
One reason for the drop in health coverage is that middle-income families can’t afford the rising cost of insurance in the individual market, particularly if they don’t qualify for government subsidies, he added.
“On balance, this is some short-term noise,” he said of the uptick in the uninsured rate. “I would put more stake in it if happens for several years.”
Chris Pope, a senior fellow with the conservative Manhattan Institute, also said he considered the change “fairly small” and likely caused by increasing wages “pushing people above the income eligibility cutoff in Medicaid expansion states.”
But he suggested that next year would be a better indicator of how changes in the ACA are playing out. “I expect that the mandate repeal will make next year’s increase in the uninsured more significant.”
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.
For the first time in a decade, the number of Americans without health insurance has risen – by about 2 million people in 2018 – according to the annual U.S. Census Bureau report released Sept. 10, 2019.
The Census found that 8.5% of the U.S. population went without medical insurance for all of 2018, up from 7.9% in 2017. By contrast, in 2013, before the Affordable Care Act took full effect, 13.3% were uninsured. It was the first year-to-year increase since 2008-09, Census officials said, adding that most of the drop in health coverage was related to a 0.7% decline in Medicaid participants. The number of people with private insurance remained steady and there was a 0.4% increase in those on Medicare.
Many of those losing coverage were noncitizens, a possible fallout from the Trump administration’s tough immigration policies and rhetoric. About 574,000 noncitizens lost coverage in 2018, a drop of about 2.3%, the report found.
“Uninsured noncitizens account for almost a third of the increase in uninsured, which may reflect the administration’s more aggressive stance on immigration,” said Joseph Antos, a health economist at the American Enterprise Institute.
The increase in the number of uninsured people in 2018 was remarkable because uninsured rates typically fall or hold steady when unemployment rates drop. The U.S. unemployment rate fell slightly from about 4.3% in 2017 to 4% in 2018.
The uninsured rate continued to vary by poverty status and whether a state expanded its Medicaid program under Obamacare. Texas (17.7%), Oklahoma (14.2%), Georgia (13.7%), and Florida (13%) had the highest uninsured rates in 2018, according to the report. None of those states have expanded Medicaid under Obamacare.
The percentage of uninsured children aged under 19 years increased by 0.6 percentage points from 2017 to 2018, to 5.5%.
“The Census data are clear – the uninsured rate for kids is up sharply and it’s due to a loss of public coverage – mostly Medicaid,” Joan Alker, executive director of Georgetown University Center for Children and Families, said in a statement.
“These children are not getting private coverage as the Trump administration has suggested but rather becoming uninsured,” she said. “This serious erosion of children’s health coverage is due in large part to the Trump administration’s actions that have made health care harder to access and have deterred families from enrolling their children.”
The share of Americans without medical insurance fell steadily since 2014 but then leveled off in 2017, the year Mr. Trump became president.
Health care advocates have complained that efforts by the Trump administration and Congress are jeopardizing insurance enrollment. They point to cuts in outreach programs that aim to tell consumers about their health care options under Obamacare and the elimination of the ACA’s tax penalty for people who don’t have health coverage.
Ms. Alker complained that the administration’s policies are causing the loss of children’s coverage. “In a period of continued economic and job growth, we shouldn’t be going backwards on health coverage,” said Judy Solomon, a senior fellow for the Center on Budget and Policy Priorities, a left-leaning think tank. “This backsliding almost certainly reflects, at least in part, Trump administration policies to weaken public health coverage.”
She attributed the drop to the Trump administration making it harder for families to enroll for coverage in Medicaid by curtailing outreach efforts, allowing states to ask for more paperwork and proposing a so-called public charge rule that would make it harder for legal immigrants to get permanent resident status if they have received certain kinds of public assistance – including Medicaid.
Tom Miller, a resident fellow at the American Enterprise Institute, a conservative think tank, said the drop in Medicaid coverage “is a positive.”
“When the economy grows Medicaid eventually drops,” he said.
One reason for the drop in health coverage is that middle-income families can’t afford the rising cost of insurance in the individual market, particularly if they don’t qualify for government subsidies, he added.
“On balance, this is some short-term noise,” he said of the uptick in the uninsured rate. “I would put more stake in it if happens for several years.”
Chris Pope, a senior fellow with the conservative Manhattan Institute, also said he considered the change “fairly small” and likely caused by increasing wages “pushing people above the income eligibility cutoff in Medicaid expansion states.”
But he suggested that next year would be a better indicator of how changes in the ACA are playing out. “I expect that the mandate repeal will make next year’s increase in the uninsured more significant.”
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.
Death by a thousand clicks
Where electronic health records went wrong.
The pain radiated from the top of Annette Monachelli’s head, and it got worse when she changed positions. It didn’t feel like her usual migraine. The 47-year-old Vermont attorney turned innkeeper visited her local doctor at the Stowe Family Practice twice about the problem in late November 2012, but got little relief.
Two months later, Monachelli was dead of an aneurysm, a condition that, despite the symptoms and the appointments, had never been tested for or diagnosed until she turned up in the emergency room days before her death.
Monachelli’s husband sued Stowe, the federally qualified health center the physician worked for. Owen Foster, a newly hired assistant U.S. attorney with the District of Vermont, was assigned to defend the government. Though it looked to be a standard medical malpractice case, Foster was on the cusp of discovering something much bigger – what his boss, U.S. Attorney Christina Nolan, calls the “frontier of health care fraud” – and prosecuting a first-of-its-kind case that landed the largest-ever financial recovery in Vermont’s history.
Foster began with Monachelli’s medical records, which offered a puzzle. Her doctor had considered the possibility of an aneurysm and, to rule it out, had ordered a head scan through the clinic’s software system, the government alleged in court filings. The test, in theory, would have caught the bleeding in Monachelli’s brain. But the order never made it to the lab; it had never been transmitted.
The software in question was an electronic health records system, or EHR, made by eClinicalWorks (eCW), one of the leading sellers of record-keeping software for physicians in America, currently used by 850,000 health professionals in the U.S. It didn’t take long for Foster to assemble a dossier of troubling reports – Better Business Bureau complaints, issues flagged on an eCW user board, and legal cases filed around the country – suggesting the company’s technology didn’t work quite the way it said it did.
Until this point, Foster, like most Americans, knew next to nothing about electronic medical records, but he was quickly amassing clues that eCW’s software had major problems – some of which put patients, like Annette Monachelli, at risk.
Damning evidence came from a whistleblower claim filed in 2011 against the company. Brendan Delaney, a British cop turned EHR expert, was hired in 2010 by New York City to work on the eCW implementation at Rikers Island, a jail complex that then had more than 100,000 inmates. But soon after he was hired, Delaney noticed scores of troubling problems with the system, which became the basis for his lawsuit. The patient medication lists weren’t reliable; prescribed drugs would not show up, while discontinued drugs would appear as current, according to the complaint. The EHR would sometimes display one patient’s medication profile accompanied by the physician’s note for a different patient, making it easy to misdiagnose or prescribe a drug to the wrong individual. Prescriptions, some 30,000 of them in 2010, lacked proper start and stop dates, introducing the opportunity for under- or overmedication. The eCW system did not reliably track lab results, concluded Delaney, who tallied 1,884 tests for which they had never gotten outcomes.
The District of Vermont launched an official federal investigation in 2015.
The eCW spaghetti code was so buggy that when one glitch got fixed, another would develop, the government found. The user interface offered a few ways to order a lab test or diagnostic image, for example, but not all of them seemed to function. The software would detect and warn users of dangerous drug interactions, but unbeknownst to physicians, the alerts stopped if the drug order was customized. “It would be like if I was driving with the radio on and the windshield wipers going and when I hit the turn signal, the brakes suddenly didn’t work,” said Foster.
The eCW system also failed to use the standard drug codes and, in some instances, lab and diagnosis codes as well, the government alleged.
The case never got to a jury. In May 2017, eCW paid a $155 million settlement to the government over alleged “false claims” and kickbacks – one physician made tens of thousands of dollars – to clients who promoted its product. Despite the record settlement, the company denied wrongdoing; eCW did not respond to numerous requests for comment.
If there is a kicker to this tale, it is this: The U.S. government bankrolled the adoption of this software – and continues to pay for it. Or we should say: You do.
Which brings us to the strange, sad, and aggravating story that unfolds below. It is not about one lawsuit or a piece of sloppy technology. Rather, it’s about a trouble-prone industry that intersects, in the most personal way, with every one of our lives. It’s about a $3.7 trillion health care system idling at the crossroads of progress. And it’s about a slew of unintended consequences – the surprising casualties of a big idea whose time had seemingly come.
The virtual magic bullet
Electronic health records were supposed to do a lot: make medicine safer, bring higher-quality care, empower patients, and yes, even save money. Boosters heralded an age when researchers could harness the big data within to reveal the most effective treatments for disease and sharply reduce medical errors. Patients, in turn, would have truly portable health records, being able to share their medical histories in a flash with doctors and hospitals anywhere in the country – essential when life-and-death decisions are being made in the ER.
But 10 years after President Barack Obama signed a law to accelerate the digitization of medical records – with the federal government, so far, sinking $36 billion into the effort – America has little to show for its investment. KHN and Fortune spoke with more than 100 physicians, patients, IT experts and administrators, health policy leaders, attorneys, top government officials and representatives at more than a half-dozen EHR vendors, including the CEOs of two of the companies. The interviews reveal a tragic missed opportunity: Rather than an electronic ecosystem of information, the nation’s thousands of EHRs largely remain a sprawling, disconnected patchwork. Moreover, the effort has handcuffed health providers to technology they mostly can’t stand and has enriched and empowered the $13-billion-a-year industry that sells it.
By one measure, certainly, the effort has achieved what it set out to do: Today, 96% of hospitals have adopted EHRs, up from just 9% in 2008. But on most other counts, the newly installed technology has fallen well short. Physicians complain about clumsy, unintuitive systems and the number of hours spent clicking, typing and trying to navigate them – which is more than the hours they spend with patients. Unlike, say, with the global network of ATMs, the proprietary EHR systems made by more than 700 vendors routinely don’t talk to one another, meaning that doctors still resort to transferring medical data via fax and CD-ROM. Patients, meanwhile, still struggle to access their own records – and, sometimes, just plain can’t.
Instead of reducing costs, many say, EHRs, which were originally optimized for billing rather than for patient care, have instead made it easier to engage in “upcoding” or bill inflation (though some say the systems also make such fraud easier to catch).
More gravely still, a months-long joint investigation by KHN and Fortune has found that instead of streamlining medicine, the government’s EHR initiative has created a host of largely unacknowledged patient safety risks. Our investigation found that alarming reports of patient deaths, serious injuries and near misses – thousands of them – tied to software glitches, user errors or other flaws have piled up, largely unseen, in various government-funded and private repositories.
Compounding the problem are entrenched secrecy policies that continue to keep software failures out of public view. EHR vendors often impose contractual “gag clauses” that discourage buyers from speaking out about safety issues and disastrous software installations – though some customers have taken to the courts to air their grievances. Plaintiffs, moreover, say hospitals often fight to withhold records from injured patients or their families. Indeed, two doctors who spoke candidly about the problems they faced with EHRs later asked that their names not be used, adding that they were forbidden by their health care organizations to talk. Says Assistant U.S. Attorney Foster, the EHR vendors “are protected by a shield of silence.”
Though the software has reduced some types of clinical mistakes common in the era of handwritten notes, Raj Ratwani, a researcher at MedStar Health in Washington, D.C., has documented new patterns of medical errors tied to EHRs that he believes are both perilous and preventable. “The fact that we’re not able to broadcast that nationally and solve these issues immediately, and that another patient somewhere else may be harmed by the very same issue – that just can’t happen,” he said.
David Blumenthal, who, as Obama’s national coordinator for health information technology, was one of the architects of the EHR initiative, acknowledged to KHN and Fortune that electronic health records “have not fulfilled their potential. I think few would argue they have.”
The former president has likewise singled out the effort as one of his most disappointing, bemoaning in a January 2017 interview with Vox “the fact that there are still just mountains of paperwork ... and the doctors still have to input stuff, and the nurses are spending all their time on all this administrative work. We put a big slug of money into trying to encourage everyone to digitalize, to catch up with the rest of the world ... that’s been harder than we expected.”
Seema Verma, the current chief of the Centers for Medicare & Medicaid Services (CMS), which oversees the EHR effort today, shudders at the billions of dollars spent building software that doesn’t share data – an electronic bridge to nowhere. “Providers developed their own systems that may or may not even have worked well for them,” she told KHN and Fortune in an interview last month, “but we didn’t think about how all these systems connect with one another. That was the real missing piece.”
Perhaps none of the initiative’s former boosters is quite as frustrated as former Vice President Joe Biden. At a 2017 meeting with health care leaders in Washington, he railed against the infuriating challenge of getting his son Beau’s medical records from one hospital to another. “I was stunned when my son for a year was battling stage 4 glioblastoma,” said Biden. “I couldn’t get his records. I’m the vice president of the United States of America. ... It was an absolute nightmare. It was ridiculous, absolutely ridiculous, that we’re in that circumstance.”
A bridge to nowhere
As Biden would tell you, the original concept was a smart one. The wave of digitization had swept up virtually every industry, bringing both disruption and, in most cases, greater efficiency. And perhaps none of these industries was more deserving of digital liberation than medicine, where life-measuring and potentially lifesaving data was locked away in paper crypts – stack upon stack of file folders at doctors’ offices across the country.
Stowed in steel cabinets, the records were next to useless. Nobody – particularly at the dawn of the age of the iPhone – thought it was a good idea to leave them that way. The problem, say critics, was in the way that policymakers set about to transform them.
“Every single idea was well-meaning and potentially of societal benefit, but the combined burden of all of them hitting clinicians simultaneously made office practice basically impossible,” said John Halamka, chief information officer at Beth Israel Deaconess Medical Center, who served on the EHR standards committees under both President George W. Bush and President Obama. “In America, we have 11 minutes to see a patient, and, you know, you’re going to be empathetic, make eye contact, enter about 100 pieces of data, and never commit malpractice. It’s not possible!”
KHN and Fortune examined more than two dozen medical negligence cases that have alleged that EHRs either contributed to injuries, had been improperly altered, or were withheld from patients to conceal substandard care. In such cases, the suits typically settle prior to trial with strict confidentiality pledges, so it’s often not possible to determine the merits of the allegations. EHR vendors also frequently have contract stipulations, known as “hold harmless clauses,” that protect them from liability if hospitals are later sued for medical errors – even if they relate to an issue with the technology.
But lawsuits, like that filed by Fabian Ronisky, which do emerge from this veil, are quite telling.
Ronisky, according to his complaint, arrived by ambulance at Providence Saint John’s Health Center in Santa Monica on the afternoon of March 2, 2015. For two days, the young lawyer had been suffering from severe headaches while a disorienting fever left him struggling to tell the 911 operator his address.
Suspecting meningitis, a doctor at the hospital performed a spinal tap, and the next day an infectious disease specialist typed in an order for a critical lab test – a check of the spinal fluid for viruses, including herpes simplex – into the hospital’s EHR.
The multimillion-dollar system, manufactured by Epic Systems Corp. and considered by some to be the Cadillac of medical software, had been installed at the hospital about four months earlier. Although the order appeared on Epic’s screen, it was not sent to the lab. It turned out, Epic’s software didn’t fully “interface” with the lab’s software, according to a lawsuit Ronisky filed in February 2017 in Los Angeles County Superior Court. His results and diagnosis were delayed – by days, he claimed – during which time he suffered irreversible brain damage from herpes encephalitis. The suit alleged the mishap delayed doctors from giving Ronisky a drug called acyclovir that might have minimized damage to his brain.
Epic denied any liability or defects in its software; the company said the doctor failed to push the right button to send the order and that the hospital, not Epic, had configured the interface with the lab. Epic, among the nation’s largest manufacturers of computerized health records and the leading provider to most of America’s most elite medical centers, quietly paid $1 million to settle the suit in July 2018, according to court records. The hospital and two doctors paid a total of $7.5 million, and a case against a third doctor is pending trial. Ronisky, 34, who is fighting to rebuild his life, declined to comment.
Incidents like that which happened to Ronisky – or to Annette Monachelli, for that matter – are surprisingly common, data show. And the back-and-forth about where the fault lies in such cases is actually part of the problem: The systems are often so confusing (and training on them seldom sufficient) that errors frequently fall into a nether zone of responsibility. It can be hard to tell where human error begins and the technological shortcomings end.
EHRs promised to put all of a patient’s records in one place, but often that’s the problem. Critical or time-sensitive information routinely gets buried in an endless scroll of data, where in the rush of medical decision-making – and amid the maze of pulldown menus – it can be missed.
Thirteen-year-old Brooke Dilliplaine, who was severely allergic to dairy, was given a probiotic containing milk. The two doses sent her into “complete respiratory distress” and resulted in a collapsed lung, according to a lawsuit filed by her mother. Rory Staunton, 12, scraped his arm in gym class and then died of sepsis after ER doctors discharged the boy on the basis of lab results in the EHR that weren’t complete. And then there’s the case of Thomas Eric Duncan. The 42-year-old man was sent home in 2014 from a Dallas hospital infected with Ebola virus. Though a nurse had entered in the EHR his recent travel to Liberia, where an Ebola epidemic was then in full swing, the doctor never saw it. Duncan died a week later.
Many such cases end up in court. Typically, doctors and nurses blame faulty technology in the medical-records systems. The EHR vendors blame human error. And meanwhile, the cases mount.
Quantros, a private health care analytics firm, said it has logged 18,000 EHR-related safety events from 2007 through 2018, 3 percent of which resulted in patient harm, including seven deaths – a figure that a Quantros director said is “drastically underreported.”
A 2016 study by The Leapfrog Group, a patient-safety watchdog based in Washington, D.C., found that the medication-ordering function of hospital EHRs – a feature required by the government for certification but often configured differently in each system – failed to flag potentially harmful drug orders in 39 percent of cases in a test simulation. In 13 percent of those cases, the mistake could have been fatal
The Pew Charitable Trusts has, for the past few years, run an EHR safety project, taking aim at issues like usability and patient matching – the process of linking the correct medical record to the correct patient – a seemingly basic task at which the systems, even when made by the same EHR vendor, often fail. At some institutions, according to Pew, such matching was accurate only 50 percent of the time. Patients have discovered mistakes as well: A January survey by the Kaiser Family Foundation found that 1 in 5 patients spotted an error in their electronic medical records. (Kaiser Health News is an editorially independent program of the foundation.)
The Joint Commission, which certifies hospitals, has sounded alarms about a number of issues, including false alarms – which account for between 85 and 99 percent of EHR and medical device alerts. (One study by researchers at Oregon Health & Science University estimated that the average clinician working in the intensive care unit may be exposed to up to 7,000 passive alerts per day.) Such over-warning can be dangerous. From 2014 to 2018, the commission tallied 170 mostly voluntary reports of patient harm related to alarm management and alert fatigue – the phenomenon in which health workers, so overloaded with unnecessary warnings, ignore the occasional meaningful one. Of those 170 incidents, 101 resulted in patient deaths.
The Pennsylvania Patient Safety Authority, an independent state agency that collects information about adverse events and incidents, counted 775 “laboratory-test problems” related to health IT from January 2016 to December 2017.
To be sure, medical errors happened en masse in the age of paper medicine, when hospital staffers misinterpreted a physician’s scrawl or read the wrong chart to deadly consequence, for instance. But what is perhaps telling is how many doctors today opt for manual workarounds to their EHRs. Aaron Zachary Hettinger, an emergency medicine physician with MedStar Health in Washington, D.C., said that when he and fellow clinicians need to share critical patient information, they write it on a whiteboard or on a paper towel and leave it on their colleagues’ computer keyboards.
While the Food and Drug Administration doesn’t mandate reporting of EHR safety events – as it does for regulated medical devices – concerned posts have nonetheless proliferated in the FDA MAUDE database of adverse events, which now serves as an ad hoc bulletin board of warnings about the various systems.
Further complicating the picture is that health providers nearly always tailor their one-size-fits-all EHR systems to their own specifications. Such customization makes every one unique and often hard to compare with others – which, in turn, makes the source of mistakes difficult to determine.
Dr. Martin Makary, a surgical oncologist at Johns Hopkins and the co-author of a much-cited 2016 study that identified medical errors as the third-leading cause of death in America, credits EHRs for some safety improvements – including recent changes that have helped put electronic brakes on the opioid epidemic. But, he said, “we’ve swapped one set of problems for another. We used to struggle with handwriting and missing information. We now struggle with a lack of visual cues to know we’re writing and ordering on the correct patient.”
Dr. Joseph Schneider, a pediatrician at UT Southwestern Medical Center, compares the transition we’ve made, from paper records to electronic ones, to moving from horses to automobiles. But in this analogy, he added, “our cars have advanced to about the 1960s. They still don’t have seat belts or air bags.”
Schneider recalled one episode when his colleagues couldn’t understand why chunks of their notes would inexplicably disappear. They figured out the problem weeks later after intense study: Physicians had been inputting squiggly brackets – {} – the use of which, unbeknownst to even vendor representatives, deleted the text between them. (The EHR maker initially blamed the doctors, said Schneider.)
A broad coalition of actors, from National Nurses United to the Texas Medical Association to leaders within the FDA, has long called for oversight on electronic-record safety issues. Among the most outspoken is Ratwani, who directs MedStar Health’s National Center on Human Factors in Healthcare, a 30-person institute focused on optimizing the safety and usability of medical technology. Ratwani spent his early career in the defense industry, studying things like the intuitiveness of information displays. When he got to MedStar in 2012, he was stunned by “the types of [digital] interfaces being used” in health care, he said.
In a study published last year in the journal Health Affairs, Ratwani and colleagues studied medication errors at three pediatric hospitals from 2012 to 2017. They discovered that 3,243 of them were owing in part to EHR “usability issues.” Roughly 1 in 5 of these could have resulted in patient harm, the researchers found. “Poor interface design and poor implementations can lead to errors and sometimes death, and that is just unbelievably bad as well as completely fixable,” he said. “We should not have patients harmed this way.”
Using eye-tracking technology, Ratwani has demonstrated on video just how easy it is to make mistakes when performing basic tasks on the nation’s two leading EHR systems. When emergency room doctors went to order Tylenol, for example, they saw a drop-down menu listing 86 options, many of which were irrelevant for the specified patient. They had to read the list carefully, so as not to click the wrong dosage or form – though many do that too: In roughly 1 out of 1,000 orders, physicians accidentally select the suppository (designated “PR”) rather than the tablet dose (“OR”), according to one estimate. That’s not an error that will harm a patient – though other medication mix-ups can and do.
Earlier this year, MedStar’s human-factors center launched a website and public awareness campaign with the American Medical Association to draw attention to such rampant mistakes – they use the letters “EHR” as an initialism for “Errors Happen Regularly” – and to petition Congress for action. Ratwani is pushing for a central database to track such errors and adverse events.
Others have turned to social media to vent. Dr. Mark Friedberg, a health-policy researcher with the Rand Corp. who is also a practicing primary care physician, champions the Twitter hashtag #EHRbuglist to encourage fellow health care workers to air their pain points. And last month, a scathing Epic parody account cropped up on Twitter, earning more than 8,000 followers in its first five days. Its maiden tweet, written in the mock voice of an Epic overlord, read: “I once saw a doctor make eye contact with a patient. This horror must stop.”
As much as EHR systems are blamed for sins of commission, it is often the sins of omission that trip up users even more.
Consider the case of Lynne Chauvin, who worked as a medical assistant at Ochsner Health System, in Louisiana. In a still-pending 2015 lawsuit, Chauvin alleges that Epic’s software failed to fire a critical medication warning; Chauvin suffered from conditions that heightened her risk for blood clots, and though that history was documented in her records, she was treated with drugs that restricted blood flow after a heart procedure at the hospital. She developed gangrene, which led to the amputation of her lower legs and forearm. (Ochsner Health System said that while it cannot comment on ongoing litigation, it “remains committed to patient safety which we strongly believe is optimized through the use of electronic health record technology.” Epic declined to comment.)
Echoing the complaints of many doctors, the suit argues that Epic software “is extremely complicated to view and understand,” owing to “significant repetition of data.” Chauvin said that her medical bills have topped $1 million and that she is permanently disabled. Her husband, Richard, has become her primary caregiver and had to retire early from his job with the city of Kenner to care for his wife, according to the suit. Each party declined to comment.
An epidemic of burnout
The numbing repetition, the box-ticking and the endless searching on pulldown menus are all part of what Ratwani called the “cognitive burden” that’s wearing out today’s physicians and driving increasing numbers into early retirement.
In recent years, “physician burnout” has skyrocketed to the top of the agenda in medicine. A 2018 Merritt Hawkins survey found a staggering 78 percent of doctors suffered symptoms of burnout, and in January the Harvard School of Public Health and other institutions deemed it a “public health crisis.”
One of the co-authors of the Harvard study, Ashish Jha, pinned much of the blame on “the growth in poorly designed digital health records ... that [have] required that physicians spend more and more time on tasks that don’t directly benefit patients.”
Few would deny that the swift digitization of America’s medical system has been transformative. With EHRs now nearly universal, the face and feel of medicine has changed. The doctor is now typing away, making more eye contact with the computer screen, perhaps, than with the patient. Patients don’t like that dynamic; for doctors, whose days increasingly begin and end with such fleeting encounters, the effect can be downright deadening.
“You’re sitting in front of a patient, and there are so many things you have to do, and you only have so much time to do it in – seven to 11 minutes, probably – so when do you really listen?” asked John-Henry Pfifferling, a medical anthropologist who counsels physicians suffering from burnout. “If you go into medicine because you care about interacting, and then you’re just a tool, it’s dehumanizing,” said Pfifferling, who has seen many physicians leave medicine over the shift to electronic records. “It’s a disaster,” he said.
Beyond complicating the physician-patient relationship, EHRs have in some ways made practicing medicine harder, said Dr. Hal Baker, a physician and the chief information officer at WellSpan, a Pennsylvania hospital system. “Physicians have to cognitively switch between focusing on the record and focusing on the patient,” he said. He points out how unusual – and potentially dangerous – this is: “Texting while you’re driving is not a good idea. And I have yet to see the CEO who, while running a board meeting, takes minutes, and certainly I’ve never heard of a judge who, during the trial, would also be the court stenographer. But in medicine ... we’ve asked the physician to move from writing in pen to [entering a computer] record, and it’s a pretty complicated interface.”
Even if docs may be at the keyboard during visits, they report having to spend hours more outside that time – at lunch, late at night – in order to finish notes and keep up with electronic paperwork (sending referrals, corresponding with patients, resolving coding issues). That’s right. EHRs didn’t take away paperwork; the systems just moved it online. And there’s a lot of it: 44 percent of the roughly six hours a physician spends on the EHR each day is focused on clerical and administrative tasks, like billing and coding, according to a 2017 Annals of Family Medicine study.
For all that so-called pajama time – the average physician logs 1.4 hours per day on the EHR after work – they don’t get a cent.
Many doctors do recognize the value in the technology: 60 percent of participants in Stanford Medicine’s 2018 National Physician Poll said EHRs had led to improved patient care. At the same time, about as many (59 percent) said EHRs needed a “complete overhaul” and that the systems had detracted from their professional satisfaction (54 percent) as well as from their clinical effectiveness (49 percent).
In preliminary studies, Ratwani has found that doctors have a typical physiological reaction to using an EHR: stress. When he and his team shadow clinicians on the job, they use a range of sensors to monitor the doctors’ heart rate and other vital signs over the course of their shift. The physicians’ heart rates will spike – as high as 160 beats per minute – on two sorts of occasions: when they are interacting with patients and when they’re using the EHR.
4,000
Approximate number of computer clicks an ER doctor makes over the course of a single shift, according to an American Journal of Emergency Medicine study
“Everything is so cumbersome,” said Dr. Karla Dick, a family medicine physician in Arlington, Texas. “It’s slow compared to a paper chart. You’re having to click and zoom in and zoom out to look for stuff.” With all the zooming in and out, she explained, it’s easy to end up in the wrong record. “I can’t tell you how many times I’ve had to cancel an order because I was in the wrong chart.”
Among the daily frustrations for one emergency room physician in Rhode Island is ordering ibuprofen, a seemingly simple task that now requires many rounds of mouse clicking. Every time she prescribes the basic painkiller for a female patient, whether that patient is 9 or 68 years old, the prescription is blocked by a pop-up alert warning her that it may be dangerous to give the drug to a pregnant woman. The physician, whose institution does not allow her to comment on the systems, must then override the warning with yet more clicks. “That’s just the tiniest tip of the iceberg,” she said.
What worries the doctor most is the ease with which diligent, well-meaning physicians can make serious medical errors. She noted that the average ER doc will make 4,000 mouse clicks over the course of a shift, and that the odds of doing anything 4,000 times without an error is small. “The interfaces are just so confusing and clunky,” she added. “They invite error ... it’s not a negligence issue. This is a poor tool issue.”
Many of the EHR makers acknowledge physician burnout is real and say they’re doing what they can to lessen the burden and enhance user experience. Dr. Sam Butler, a pulmonary critical care specialist who started working at Epic in 2001, leads those efforts at the Wisconsin-based company. When doctors get more than 100 messages per week in their in-basket (akin to an email inbox), there’s a higher likelihood of burnout. Butler’s team has also analyzed doctors’ electronic notes – they’re twice as long as they were nine years ago, and three to four times as long as notes in the rest of the world. He said Epic uses such insights to improve the client experience. But coming up with fixes is difficult because doctors “have different viewpoints on everything,” he said. (KHN and Fortune made multiple requests to interview Epic CEO Judy Faulkner, but the company declined to make her available. In a trade interview in February, however, Faulkner said that EHRs were unfairly blamed for physician burnout and cited a study suggesting that there’s little correlation between burnout and EHR satisfaction. Executives at other vendors noted that they’re aware of usability issues and that they’re working on addressing them.)
“It’s not that we’re a bunch of Luddites who don’t know how to use technology,” said the Rhode Island ER doctor. “I have an iPhone and a computer and they work the way they’re supposed to work, and then we’re given these incredibly cumbersome and error-prone tools. This is something the government mandated. There really wasn’t the time to let the cream rise to the top; everyone had to jump in and pick something that worked and spend tens of millions of dollars on a system that is slowly killing us.”
$36 billion and change
The effort to digitize America’s health records got its biggest push in a very low moment: the financial crisis of 2008. In early December of that year, Obama, barely four weeks after his election, pitched an ambitious economic recovery plan. “We will make sure that every doctor’s office and hospital in this country is using cutting-edge technology and electronic medical records so that we can cut red tape, prevent medical mistakes and help save billions of dollars each year,” he said in a radio address.
The idea had already been a fashionable one in Washington. Former House Speaker Newt Gingrich was fond of saying it was easier to track a FedEx package than one’s medical records. Obama’s predecessor, President George W. Bush, had also pursued the idea of wiring up the country’s health system. He didn’t commit much money, but Bush did create an agency to do the job: the Office of the National Coordinator (ONC).
In the depths of recession, the EHR conceit looked like a shovel-ready project that only the paper lobby could hate. In February 2009, legislators passed the HITECH Act, which carved out a hefty chunk of the massive stimulus package for health information technology. The goal was not just to get hospitals and doctors to buy EHRs, but rather to get them using them in a way that would drive better care. So lawmakers devised a carrot-and-stick approach: Physicians would qualify for federal subsidies (a sum of up to nearly $64,000 over a period of years) only if they were “meaningful users” of a government-certified system. Vendors, for their part, had to develop systems that met the government’s requirements.
They didn’t have much time, though. The need to stimulate the economy, which meant getting providers to adopt EHRs quickly, “presented a tremendous conundrum,” said Farzad Mostashari, who joined the ONC as deputy director in 2009 and became its leader in 2011: The ideal – creating a useful, interoperable, nationwide records system – was “utterly infeasible to get to in a short time frame.”
That didn’t stop the federal planners from pursuing their grand ambitions. Everyone had big ideas for the EHRs. The FDA wanted the systems to track unique device identifiers for medical implants, the Centers for Disease Control and Prevention wanted them to support disease surveillance, CMS wanted them to include quality metrics and so on. “We had all the right ideas that were discussed and hashed out by the committee,” said Mostashari, “but they were all of the right ideas.”
Not everyone agreed, though, that they were the right ideas. Before long, “meaningful use” became pejorative shorthand to many for a burdensome government program – making doctors do things like check a box indicating a patient’s smoking status each and every visit.
The EHR vendor community, then a scrappy $2 billion industry, griped at the litany of requirements but stood to gain so much from the government’s $36 billion injection that it jumped in line. As Rusty Frantz, CEO of EHR vendor NextGen Healthcare, put it: “The industry was like, ‘I’ve got this check dangling in front of me, and I have to check these boxes to get there, and so I’m going to do that.’”
Halamka, who was an enthusiastic backer of the initiative in both the Bush and Obama administrations, blames the pressure for a speedy launch as much as the excessive wish list. “To go from a regulation to a highly usable product that is in the hands of doctors in 18 months, that’s too fast,” he said. “It’s like asking nine women to have a baby in a month.”
Several of those who worked on the project admit the rollout was not as easy or seamless as they’d anticipated, but they contend that was never the point. Aneesh Chopra, appointed by Obama in 2009 as the nation’s first chief technology officer, called the spending a “down payment” on a vision to fundamentally change American medicine – creating a digital infrastructure to support new ways to pay for health services based on their quality and outcomes.
Dr. Bob Kocher, a physician and star investor with venture capital firm Venrock, who served in the Obama administration from 2009 to 2011 as a health and economic policy adviser, not only defends the rollout then but also disputes the notion that the government initiative has been a failure at all. “EHRs have totally lived up to the hype and expectations,” he said, emphasizing that they also serve as a technology foundation to support innovation on everything from patients accessing their medical records on a smartphone to AI-driven medical sleuthing. Others note the systems’ value in aggregating medical data in ways that were never possible with paper – helping, for example, to figure out that contaminated water was poisoning children in Flint, Mich.
But Rusty Frantz heard a far different message about EHRs – and, more important, it was coming from his own customers.
The Stanford-trained engineer, who in 2015 became CEO of NextGen, a $500-million-a-year EHR heavyweight in the physician-office market, learned the hard way about how his product was being viewed. As he stood at the podium at his first meeting with thousands of NextGen customers at Las Vegas’ Mandalay Bay Resort, just four months after getting the job, he told KHN and Fortune, “People were lining up at the microphones to yell at us: ‘We weren’t delivering stable software! The executive team was inaccessible! The service experience was terrible!’ ” (He now refers to the event as “Festivus: the airing of the grievances.”)
Frantz had bounced around the health care industry for much of his career, and from the nearby perch of a medical device company, he watched the EHR incentive bonanza with a mix of envy and slack-jawed awe. “The industry was moving along in a natural Darwinist way, and then along came the stimulus,” said Frantz, who blames the government’s ham-handed approach to regulation. “The software got slammed in, and the software wasn’t implemented in a way that supported care,” he said. “It was installed in a way that supported stimulus. This company, we were complicit in it, too.”
Even that may be a generous description. KHN and Fortune found a trail of lawsuits against the company, stretching from White Sulphur Springs, Mont., to Neillsville, Wis. Mary Rutan Hospital in Bellefontaine, Ohio, sued NextGen (formerly called Quality Systems) in federal court in 2013, arguing that it experienced hundreds of problems with the “materially defective” software the company had installed in 2011.
A consultant hired by the hospital to evaluate the NextGen system, whose 60-page report was submitted to the court, identified “many functional defects” that he said rendered the software “unfit for its intended purpose.” Some patient information was not accurately recorded, which had the potential, the consultant wrote, “to create major patient care risk which could lead to, at a minimum, inconvenience, and at worst, malpractice or even death.” Glitches at Mary Rutan included incidents in which the software would apparently change a patient’s gender at random or lose a doctor’s observations after an exam, the consultant reported. The company, he found, sometimes took months to address issues: One IT ticket, which related to a physician’s notes inexplicably deleting themselves, reportedly took 10 months to resolve. (The consultant also noted that similar problems appeared to be occurring at as many as a dozen other hospitals that had installed NextGen software.)
The Ohio hospital, which paid more than $1.5 million for its EHR system, claimed breach of contract. NextGen responded that it disputed the claims made in the lawsuit and that the matter was resolved in 2015 “with no findings of fact by a court related to the allegations.” The hospital declined to comment.
At the time, as it has been since then, NextGen’s software was certified by the government as meeting the requirements of the stimulus program. By 2016, NextGen had more than 19,000 customers who had received federal subsidies.
NextGen was subpoenaed by the Department of Justice in December 2017, months after becoming the subject of a federal investigation led by the District of Vermont. Frantz tells KHN and Fortune that NextGen is cooperating with the investigation. “This company was not dishonest, but it was not effective four years ago,” he said. Frantz also emphasized that NextGen has “rapidly evolved” during his tenure, earning five industry awards since 2017, and that customers have “responded very positively.”
Glen Tullman, who until 2012 led Allscripts, another leading EHR vendor that benefited royally from the stimulus and that has been sued by numerous unhappy customers, admitted that the industry’s race to market took priority over all else.
“It was a big distraction. That was an unintended consequence of that,” Tullman said. “All the companies were saying, This is a one-time opportunity to expand our share, focus everything there, and then we’ll go back and fix it.” The Justice Department has opened a civil investigation into the company, Securities and Exchange Commission filings show. Allscripts said in an email that it cannot comment on an ongoing investigation, but that the civil investigations by the Department of Justice relate to businesses it acquired after the investigations were opened.
Much of the marketing mayhem occurred because federal officials imposed few controls over firms scrambling to cash in on the stimulus. It was a gold rush – and any system, it seemed, could be marketed as “federally approved.” Doctors could shop for bargain-price software packages at Costco and Walmart’s Sam’s Club – where eClinicalWorks sold a “turnkey” system for $11,925 – and cash in on the government’s adoption incentives.
The top-shelf vendors in 2009 crisscrossed the country on a “stimulus tour” like rock groups, gigging at some 30 cities, where they offered doctors who showed up to hear the pitch “a customized analysis” of how much money they could earn off the government incentives. Following the same playbook used by pharmaceutical companies, EHR sellers courted doctors at fancy dinners in ritzy hotels. One enterprising software firm advertised a “cash for clunkers” deal that paid $3,000 to doctors willing to trade in their current records system for a new one. Athenahealth held “invitation only” dinners at luxury hotels to advise doctors, among other things, how to use the stimulus to get paid more and capture available incentives. Allscripts offered a no-money-down purchase plan to help doctors “maximize the return on your EHR investment.” (An Athenahealth spokesperson said the company’s “dinners were educational in nature and aimed at helping physicians navigate the government program.” Allscripts did not respond directly to questions about its marketing practices, but said it “is proud of the software and services [it provides] to hundreds of thousands of caregivers across the globe.”)
EHRs were supposed to reduce health care costs, at least in part by preventing duplicative tests. But as the federal government opened the stimulus tap, many raised doubts about the promised savings. Advocates bandied about a figure of $80 billion in cost savings even as congressional auditors were debunking it. While the jury’s still out, there’s growing suspicion the digital revolution may potentially raise health care costs by encouraging overbilling and new strains of fraud and abuse.
In September 2012, following press reports suggesting that some doctors and hospitals were using the new technology to improperly boost their fees, a practice known as “upcoding,” then-Health and Human Services chief Kathleen Sebelius and Attorney General Eric Holder warned the industry not to try to “game the system.”
There’s also growing evidence that some doctors and health systems may have overstated their use of the new technology to secure stimulus funds, a potentially enormous fraud against Medicare and Medicaid that likely will take many years to unravel. In June 2017, the HHS inspector general estimated that Medicare officials made more than $729 million in subsidy payments to hospitals and doctors that didn’t deserve them.
Individual states, which administer the Medicaid portion of the program, haven’t fared much better. Audits have uncovered overpayments in 14 of 17 state programs reviewed, totaling more than $66 million, according to inspector general reports.
Last month, Sen. Chuck Grassley, an Iowa Republican who chairs the Senate Finance Committee, sharply criticized CMS for recovering only a tiny fraction of these bogus payments, or what he termed a “spit in the ocean.”
EHR vendors have also been accused of egregious and patient-endangering acts of fraud as they raced to cash in on the stimulus money grab. In addition to the U.S. government’s $155 million False Claims Act settlement with eClinicalWorks noted above, the federal government has reached a second settlement over similar charges against another large vendor, Tampa-based Greenway Health. In February, that company settled with the government for just over $57 million without denying or admitting wrongdoing. “These are cases of corporate greed, companies that prioritized profits over everything else,” said Christina Nolan, the U.S. attorney for the District of Vermont, whose office led the cases. (In a response, Greenway Health did not address the charges or the settlement but said it was “committing itself to being the standard-bearer for quality, compliance, and transparency.”)
Tower of Babel
In early 2017, Seema Verma, then the country’s newly appointed CMS administrator, went on a listening tour. She visited doctors around the country, at big urban practices and tiny rural clinics, and from those front-line physicians she consistently heard one thing: They hated their electronic health records. “Physician burnout is real,” she told KHN and Fortune. The doctors spoke of the difficulty in getting information from other systems and providers, and they complained about the government’s reporting requirements, which they perceived as burdensome and not meaningful.
What she heard then became suddenly personal one summer day in 2017, when her husband, himself a physician, collapsed in the airport on his way home to Indianapolis after a family vacation. For a frantic few hours, the CMS administrator fielded phone calls from first responders and physicians – Did she know his medical history? Did she have information that could save his life? – and made calls to his doctors in Indiana, scrambling to piece together his record, which should have been there in one piece. Her husband survived the episode, but it laid bare the dysfunction and danger inherent in the existing health information ecosystem.
The notion that one EHR should talk to another was a key part of the original vision for the HITECH Act, with the government calling for systems to be eventually interoperable.
What the framers of that vision didn’t count on were the business incentives working against it. A free exchange of information means that patients can be treated anywhere. And though they may not admit it, many health providers are loath to lose their patients to a competing doctor’s office or hospital. There’s a term for that lost revenue: “leakage.” And keeping a tight hold on patients’ medical records is one way to prevent it.
There’s a ton of proprietary value in that data, said Blumenthal, who now heads the Commonwealth Fund, a philanthropy that does health research. Asking hospitals to give it up is “like asking Amazon to share their data with Walmart,” he said.
Blumenthal acknowledged that he failed to grasp these perverse business dynamics and foresee what a challenge getting the systems to talk to one another would be. He added that forcing interoperability goals early on, when 90 percent of the nation’s providers still didn’t have systems or data to exchange, seemed unrealistic. “We had an expression: They had to operate before they could interoperate,” he said.
In the absence of true incentives for systems to communicate, the industry limped along; some providers wired up directly to other select providers or through regional exchanges, but the efforts were spotty. A Cerner-backed interoperability network called CommonWell formed in 2013, but some companies, including dominant Epic, didn’t join. (“Initially, Epic was neither invited nor allowed to join,” said Sumit Rana, senior vice president of R&D at Epic. Jitin Asnaani, executive director of CommonWell countered, “We made repeated invitations to every major EHR ... and numerous public and private invitations to Epic.”)
Epic then supported a separate effort to do much the same.
Last spring, Verma attempted to kick-start the sharing effort and later pledged a war on “information blocking,” threatening penalties for bad actors. She has promised to reduce the documentation burden on physicians and end the gag clauses that protect the EHR industry. Regarding the first effort at least, “there was consensus that this needed to happen and that it would take the government to push this forward,” she said. In one sign of progress last summer, the dueling sharing initiatives of Epic and Cerner, the two largest players in the industry, began to share with each other – though the effort is fledgling.
When it comes to patients, though, the real sharing too often stops. Despite federal requirements that providers give patients their medical records in a timely fashion, in their chosen format and at low cost (the government recommends a flat fee of $6.50 or less), patients struggle mightily to get them. A 2017 study by researchers at Yale found that of America’s 83 top-rated hospitals, only 53 percent offer forms that provide patients with the option to receive their entire medical record. Fewer than half would share records via email. One hospital charged more than $500 to release them.
Sometimes the mere effort to access records leads to court. Jennifer De Angelis, a Tulsa attorney, has frequently sparred with hospitals over releasing her clients’ records. She said they either attempt to charge huge sums for them or force her to obtain a court order before releasing them. De Angelis added that she sometimes suspects the records have been overwritten to cover up medical mistakes.
Consider the case of 5-year-old Uriah R. Roach, who fractured and cut his finger on Oct. 2, 2014, when it was accidentally slammed in a door at school. Five days later, an operation to repair the damage went awry, and he suffered permanent brain damage, apparently owing to an anesthesia problem. The Epic electronic medical file had been accessed more than 76,000 times during the 22 days the boy was in the hospital, and a lawsuit brought by his parents contended that numerous entries had been “corrected, altered, modified and possibly deleted after an unexpected outcome during the induction of anesthesia.” The hospital denied wrongdoing. The case settled in November 2016, and the terms are confidential.
More than a dozen other attorneys interviewed cited similar problems, especially with gaining access to computerized “audit trails.” In several cases, court records show, government lawyers resisted turning over electronic files from federally run hospitals. That happened to Russell Uselton, an Oklahoma lawyer who represented a pregnant teen admitted to the Choctaw Nation Health Care Center in Talihina, Okla. Shelby Carshall, 18, was more than 40 weeks pregnant at the time. Doctors failed to perform a cesarean section, and her baby was born brain-damaged as a result, she alleged in a lawsuit filed in 2017 against the U.S. government. The baby began having seizures at 10 hours old and will “likely never walk, talk, eat, or otherwise live normally,” according to pleadings in the suit. Though the federal government requires hospitals to produce electronic health records to patients and their families, Uselton had to obtain a court order to get the baby’s complete medical files. Government lawyers denied any negligence in the case, which is pending.
“They try to hide anything from you that they can hide from you,” said Uselton. “They make it extremely difficult to get records, so expensive and hard that most lawyers can’t take it on,” he said.
Nor, it seems, can high-ranking federal officials. When Seema Verma’s husband was discharged from the hospital after his summer health scare, he was handed a few papers and a CD-ROM containing some medical images – but missing key tests and monitoring data. Said Verma, “We left that hospital and we still don’t have his information today.” That was nearly two years ago
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.
Where electronic health records went wrong.
Where electronic health records went wrong.
The pain radiated from the top of Annette Monachelli’s head, and it got worse when she changed positions. It didn’t feel like her usual migraine. The 47-year-old Vermont attorney turned innkeeper visited her local doctor at the Stowe Family Practice twice about the problem in late November 2012, but got little relief.
Two months later, Monachelli was dead of an aneurysm, a condition that, despite the symptoms and the appointments, had never been tested for or diagnosed until she turned up in the emergency room days before her death.
Monachelli’s husband sued Stowe, the federally qualified health center the physician worked for. Owen Foster, a newly hired assistant U.S. attorney with the District of Vermont, was assigned to defend the government. Though it looked to be a standard medical malpractice case, Foster was on the cusp of discovering something much bigger – what his boss, U.S. Attorney Christina Nolan, calls the “frontier of health care fraud” – and prosecuting a first-of-its-kind case that landed the largest-ever financial recovery in Vermont’s history.
Foster began with Monachelli’s medical records, which offered a puzzle. Her doctor had considered the possibility of an aneurysm and, to rule it out, had ordered a head scan through the clinic’s software system, the government alleged in court filings. The test, in theory, would have caught the bleeding in Monachelli’s brain. But the order never made it to the lab; it had never been transmitted.
The software in question was an electronic health records system, or EHR, made by eClinicalWorks (eCW), one of the leading sellers of record-keeping software for physicians in America, currently used by 850,000 health professionals in the U.S. It didn’t take long for Foster to assemble a dossier of troubling reports – Better Business Bureau complaints, issues flagged on an eCW user board, and legal cases filed around the country – suggesting the company’s technology didn’t work quite the way it said it did.
Until this point, Foster, like most Americans, knew next to nothing about electronic medical records, but he was quickly amassing clues that eCW’s software had major problems – some of which put patients, like Annette Monachelli, at risk.
Damning evidence came from a whistleblower claim filed in 2011 against the company. Brendan Delaney, a British cop turned EHR expert, was hired in 2010 by New York City to work on the eCW implementation at Rikers Island, a jail complex that then had more than 100,000 inmates. But soon after he was hired, Delaney noticed scores of troubling problems with the system, which became the basis for his lawsuit. The patient medication lists weren’t reliable; prescribed drugs would not show up, while discontinued drugs would appear as current, according to the complaint. The EHR would sometimes display one patient’s medication profile accompanied by the physician’s note for a different patient, making it easy to misdiagnose or prescribe a drug to the wrong individual. Prescriptions, some 30,000 of them in 2010, lacked proper start and stop dates, introducing the opportunity for under- or overmedication. The eCW system did not reliably track lab results, concluded Delaney, who tallied 1,884 tests for which they had never gotten outcomes.
The District of Vermont launched an official federal investigation in 2015.
The eCW spaghetti code was so buggy that when one glitch got fixed, another would develop, the government found. The user interface offered a few ways to order a lab test or diagnostic image, for example, but not all of them seemed to function. The software would detect and warn users of dangerous drug interactions, but unbeknownst to physicians, the alerts stopped if the drug order was customized. “It would be like if I was driving with the radio on and the windshield wipers going and when I hit the turn signal, the brakes suddenly didn’t work,” said Foster.
The eCW system also failed to use the standard drug codes and, in some instances, lab and diagnosis codes as well, the government alleged.
The case never got to a jury. In May 2017, eCW paid a $155 million settlement to the government over alleged “false claims” and kickbacks – one physician made tens of thousands of dollars – to clients who promoted its product. Despite the record settlement, the company denied wrongdoing; eCW did not respond to numerous requests for comment.
If there is a kicker to this tale, it is this: The U.S. government bankrolled the adoption of this software – and continues to pay for it. Or we should say: You do.
Which brings us to the strange, sad, and aggravating story that unfolds below. It is not about one lawsuit or a piece of sloppy technology. Rather, it’s about a trouble-prone industry that intersects, in the most personal way, with every one of our lives. It’s about a $3.7 trillion health care system idling at the crossroads of progress. And it’s about a slew of unintended consequences – the surprising casualties of a big idea whose time had seemingly come.
The virtual magic bullet
Electronic health records were supposed to do a lot: make medicine safer, bring higher-quality care, empower patients, and yes, even save money. Boosters heralded an age when researchers could harness the big data within to reveal the most effective treatments for disease and sharply reduce medical errors. Patients, in turn, would have truly portable health records, being able to share their medical histories in a flash with doctors and hospitals anywhere in the country – essential when life-and-death decisions are being made in the ER.
But 10 years after President Barack Obama signed a law to accelerate the digitization of medical records – with the federal government, so far, sinking $36 billion into the effort – America has little to show for its investment. KHN and Fortune spoke with more than 100 physicians, patients, IT experts and administrators, health policy leaders, attorneys, top government officials and representatives at more than a half-dozen EHR vendors, including the CEOs of two of the companies. The interviews reveal a tragic missed opportunity: Rather than an electronic ecosystem of information, the nation’s thousands of EHRs largely remain a sprawling, disconnected patchwork. Moreover, the effort has handcuffed health providers to technology they mostly can’t stand and has enriched and empowered the $13-billion-a-year industry that sells it.
By one measure, certainly, the effort has achieved what it set out to do: Today, 96% of hospitals have adopted EHRs, up from just 9% in 2008. But on most other counts, the newly installed technology has fallen well short. Physicians complain about clumsy, unintuitive systems and the number of hours spent clicking, typing and trying to navigate them – which is more than the hours they spend with patients. Unlike, say, with the global network of ATMs, the proprietary EHR systems made by more than 700 vendors routinely don’t talk to one another, meaning that doctors still resort to transferring medical data via fax and CD-ROM. Patients, meanwhile, still struggle to access their own records – and, sometimes, just plain can’t.
Instead of reducing costs, many say, EHRs, which were originally optimized for billing rather than for patient care, have instead made it easier to engage in “upcoding” or bill inflation (though some say the systems also make such fraud easier to catch).
More gravely still, a months-long joint investigation by KHN and Fortune has found that instead of streamlining medicine, the government’s EHR initiative has created a host of largely unacknowledged patient safety risks. Our investigation found that alarming reports of patient deaths, serious injuries and near misses – thousands of them – tied to software glitches, user errors or other flaws have piled up, largely unseen, in various government-funded and private repositories.
Compounding the problem are entrenched secrecy policies that continue to keep software failures out of public view. EHR vendors often impose contractual “gag clauses” that discourage buyers from speaking out about safety issues and disastrous software installations – though some customers have taken to the courts to air their grievances. Plaintiffs, moreover, say hospitals often fight to withhold records from injured patients or their families. Indeed, two doctors who spoke candidly about the problems they faced with EHRs later asked that their names not be used, adding that they were forbidden by their health care organizations to talk. Says Assistant U.S. Attorney Foster, the EHR vendors “are protected by a shield of silence.”
Though the software has reduced some types of clinical mistakes common in the era of handwritten notes, Raj Ratwani, a researcher at MedStar Health in Washington, D.C., has documented new patterns of medical errors tied to EHRs that he believes are both perilous and preventable. “The fact that we’re not able to broadcast that nationally and solve these issues immediately, and that another patient somewhere else may be harmed by the very same issue – that just can’t happen,” he said.
David Blumenthal, who, as Obama’s national coordinator for health information technology, was one of the architects of the EHR initiative, acknowledged to KHN and Fortune that electronic health records “have not fulfilled their potential. I think few would argue they have.”
The former president has likewise singled out the effort as one of his most disappointing, bemoaning in a January 2017 interview with Vox “the fact that there are still just mountains of paperwork ... and the doctors still have to input stuff, and the nurses are spending all their time on all this administrative work. We put a big slug of money into trying to encourage everyone to digitalize, to catch up with the rest of the world ... that’s been harder than we expected.”
Seema Verma, the current chief of the Centers for Medicare & Medicaid Services (CMS), which oversees the EHR effort today, shudders at the billions of dollars spent building software that doesn’t share data – an electronic bridge to nowhere. “Providers developed their own systems that may or may not even have worked well for them,” she told KHN and Fortune in an interview last month, “but we didn’t think about how all these systems connect with one another. That was the real missing piece.”
Perhaps none of the initiative’s former boosters is quite as frustrated as former Vice President Joe Biden. At a 2017 meeting with health care leaders in Washington, he railed against the infuriating challenge of getting his son Beau’s medical records from one hospital to another. “I was stunned when my son for a year was battling stage 4 glioblastoma,” said Biden. “I couldn’t get his records. I’m the vice president of the United States of America. ... It was an absolute nightmare. It was ridiculous, absolutely ridiculous, that we’re in that circumstance.”
A bridge to nowhere
As Biden would tell you, the original concept was a smart one. The wave of digitization had swept up virtually every industry, bringing both disruption and, in most cases, greater efficiency. And perhaps none of these industries was more deserving of digital liberation than medicine, where life-measuring and potentially lifesaving data was locked away in paper crypts – stack upon stack of file folders at doctors’ offices across the country.
Stowed in steel cabinets, the records were next to useless. Nobody – particularly at the dawn of the age of the iPhone – thought it was a good idea to leave them that way. The problem, say critics, was in the way that policymakers set about to transform them.
“Every single idea was well-meaning and potentially of societal benefit, but the combined burden of all of them hitting clinicians simultaneously made office practice basically impossible,” said John Halamka, chief information officer at Beth Israel Deaconess Medical Center, who served on the EHR standards committees under both President George W. Bush and President Obama. “In America, we have 11 minutes to see a patient, and, you know, you’re going to be empathetic, make eye contact, enter about 100 pieces of data, and never commit malpractice. It’s not possible!”
KHN and Fortune examined more than two dozen medical negligence cases that have alleged that EHRs either contributed to injuries, had been improperly altered, or were withheld from patients to conceal substandard care. In such cases, the suits typically settle prior to trial with strict confidentiality pledges, so it’s often not possible to determine the merits of the allegations. EHR vendors also frequently have contract stipulations, known as “hold harmless clauses,” that protect them from liability if hospitals are later sued for medical errors – even if they relate to an issue with the technology.
But lawsuits, like that filed by Fabian Ronisky, which do emerge from this veil, are quite telling.
Ronisky, according to his complaint, arrived by ambulance at Providence Saint John’s Health Center in Santa Monica on the afternoon of March 2, 2015. For two days, the young lawyer had been suffering from severe headaches while a disorienting fever left him struggling to tell the 911 operator his address.
Suspecting meningitis, a doctor at the hospital performed a spinal tap, and the next day an infectious disease specialist typed in an order for a critical lab test – a check of the spinal fluid for viruses, including herpes simplex – into the hospital’s EHR.
The multimillion-dollar system, manufactured by Epic Systems Corp. and considered by some to be the Cadillac of medical software, had been installed at the hospital about four months earlier. Although the order appeared on Epic’s screen, it was not sent to the lab. It turned out, Epic’s software didn’t fully “interface” with the lab’s software, according to a lawsuit Ronisky filed in February 2017 in Los Angeles County Superior Court. His results and diagnosis were delayed – by days, he claimed – during which time he suffered irreversible brain damage from herpes encephalitis. The suit alleged the mishap delayed doctors from giving Ronisky a drug called acyclovir that might have minimized damage to his brain.
Epic denied any liability or defects in its software; the company said the doctor failed to push the right button to send the order and that the hospital, not Epic, had configured the interface with the lab. Epic, among the nation’s largest manufacturers of computerized health records and the leading provider to most of America’s most elite medical centers, quietly paid $1 million to settle the suit in July 2018, according to court records. The hospital and two doctors paid a total of $7.5 million, and a case against a third doctor is pending trial. Ronisky, 34, who is fighting to rebuild his life, declined to comment.
Incidents like that which happened to Ronisky – or to Annette Monachelli, for that matter – are surprisingly common, data show. And the back-and-forth about where the fault lies in such cases is actually part of the problem: The systems are often so confusing (and training on them seldom sufficient) that errors frequently fall into a nether zone of responsibility. It can be hard to tell where human error begins and the technological shortcomings end.
EHRs promised to put all of a patient’s records in one place, but often that’s the problem. Critical or time-sensitive information routinely gets buried in an endless scroll of data, where in the rush of medical decision-making – and amid the maze of pulldown menus – it can be missed.
Thirteen-year-old Brooke Dilliplaine, who was severely allergic to dairy, was given a probiotic containing milk. The two doses sent her into “complete respiratory distress” and resulted in a collapsed lung, according to a lawsuit filed by her mother. Rory Staunton, 12, scraped his arm in gym class and then died of sepsis after ER doctors discharged the boy on the basis of lab results in the EHR that weren’t complete. And then there’s the case of Thomas Eric Duncan. The 42-year-old man was sent home in 2014 from a Dallas hospital infected with Ebola virus. Though a nurse had entered in the EHR his recent travel to Liberia, where an Ebola epidemic was then in full swing, the doctor never saw it. Duncan died a week later.
Many such cases end up in court. Typically, doctors and nurses blame faulty technology in the medical-records systems. The EHR vendors blame human error. And meanwhile, the cases mount.
Quantros, a private health care analytics firm, said it has logged 18,000 EHR-related safety events from 2007 through 2018, 3 percent of which resulted in patient harm, including seven deaths – a figure that a Quantros director said is “drastically underreported.”
A 2016 study by The Leapfrog Group, a patient-safety watchdog based in Washington, D.C., found that the medication-ordering function of hospital EHRs – a feature required by the government for certification but often configured differently in each system – failed to flag potentially harmful drug orders in 39 percent of cases in a test simulation. In 13 percent of those cases, the mistake could have been fatal
The Pew Charitable Trusts has, for the past few years, run an EHR safety project, taking aim at issues like usability and patient matching – the process of linking the correct medical record to the correct patient – a seemingly basic task at which the systems, even when made by the same EHR vendor, often fail. At some institutions, according to Pew, such matching was accurate only 50 percent of the time. Patients have discovered mistakes as well: A January survey by the Kaiser Family Foundation found that 1 in 5 patients spotted an error in their electronic medical records. (Kaiser Health News is an editorially independent program of the foundation.)
The Joint Commission, which certifies hospitals, has sounded alarms about a number of issues, including false alarms – which account for between 85 and 99 percent of EHR and medical device alerts. (One study by researchers at Oregon Health & Science University estimated that the average clinician working in the intensive care unit may be exposed to up to 7,000 passive alerts per day.) Such over-warning can be dangerous. From 2014 to 2018, the commission tallied 170 mostly voluntary reports of patient harm related to alarm management and alert fatigue – the phenomenon in which health workers, so overloaded with unnecessary warnings, ignore the occasional meaningful one. Of those 170 incidents, 101 resulted in patient deaths.
The Pennsylvania Patient Safety Authority, an independent state agency that collects information about adverse events and incidents, counted 775 “laboratory-test problems” related to health IT from January 2016 to December 2017.
To be sure, medical errors happened en masse in the age of paper medicine, when hospital staffers misinterpreted a physician’s scrawl or read the wrong chart to deadly consequence, for instance. But what is perhaps telling is how many doctors today opt for manual workarounds to their EHRs. Aaron Zachary Hettinger, an emergency medicine physician with MedStar Health in Washington, D.C., said that when he and fellow clinicians need to share critical patient information, they write it on a whiteboard or on a paper towel and leave it on their colleagues’ computer keyboards.
While the Food and Drug Administration doesn’t mandate reporting of EHR safety events – as it does for regulated medical devices – concerned posts have nonetheless proliferated in the FDA MAUDE database of adverse events, which now serves as an ad hoc bulletin board of warnings about the various systems.
Further complicating the picture is that health providers nearly always tailor their one-size-fits-all EHR systems to their own specifications. Such customization makes every one unique and often hard to compare with others – which, in turn, makes the source of mistakes difficult to determine.
Dr. Martin Makary, a surgical oncologist at Johns Hopkins and the co-author of a much-cited 2016 study that identified medical errors as the third-leading cause of death in America, credits EHRs for some safety improvements – including recent changes that have helped put electronic brakes on the opioid epidemic. But, he said, “we’ve swapped one set of problems for another. We used to struggle with handwriting and missing information. We now struggle with a lack of visual cues to know we’re writing and ordering on the correct patient.”
Dr. Joseph Schneider, a pediatrician at UT Southwestern Medical Center, compares the transition we’ve made, from paper records to electronic ones, to moving from horses to automobiles. But in this analogy, he added, “our cars have advanced to about the 1960s. They still don’t have seat belts or air bags.”
Schneider recalled one episode when his colleagues couldn’t understand why chunks of their notes would inexplicably disappear. They figured out the problem weeks later after intense study: Physicians had been inputting squiggly brackets – {} – the use of which, unbeknownst to even vendor representatives, deleted the text between them. (The EHR maker initially blamed the doctors, said Schneider.)
A broad coalition of actors, from National Nurses United to the Texas Medical Association to leaders within the FDA, has long called for oversight on electronic-record safety issues. Among the most outspoken is Ratwani, who directs MedStar Health’s National Center on Human Factors in Healthcare, a 30-person institute focused on optimizing the safety and usability of medical technology. Ratwani spent his early career in the defense industry, studying things like the intuitiveness of information displays. When he got to MedStar in 2012, he was stunned by “the types of [digital] interfaces being used” in health care, he said.
In a study published last year in the journal Health Affairs, Ratwani and colleagues studied medication errors at three pediatric hospitals from 2012 to 2017. They discovered that 3,243 of them were owing in part to EHR “usability issues.” Roughly 1 in 5 of these could have resulted in patient harm, the researchers found. “Poor interface design and poor implementations can lead to errors and sometimes death, and that is just unbelievably bad as well as completely fixable,” he said. “We should not have patients harmed this way.”
Using eye-tracking technology, Ratwani has demonstrated on video just how easy it is to make mistakes when performing basic tasks on the nation’s two leading EHR systems. When emergency room doctors went to order Tylenol, for example, they saw a drop-down menu listing 86 options, many of which were irrelevant for the specified patient. They had to read the list carefully, so as not to click the wrong dosage or form – though many do that too: In roughly 1 out of 1,000 orders, physicians accidentally select the suppository (designated “PR”) rather than the tablet dose (“OR”), according to one estimate. That’s not an error that will harm a patient – though other medication mix-ups can and do.
Earlier this year, MedStar’s human-factors center launched a website and public awareness campaign with the American Medical Association to draw attention to such rampant mistakes – they use the letters “EHR” as an initialism for “Errors Happen Regularly” – and to petition Congress for action. Ratwani is pushing for a central database to track such errors and adverse events.
Others have turned to social media to vent. Dr. Mark Friedberg, a health-policy researcher with the Rand Corp. who is also a practicing primary care physician, champions the Twitter hashtag #EHRbuglist to encourage fellow health care workers to air their pain points. And last month, a scathing Epic parody account cropped up on Twitter, earning more than 8,000 followers in its first five days. Its maiden tweet, written in the mock voice of an Epic overlord, read: “I once saw a doctor make eye contact with a patient. This horror must stop.”
As much as EHR systems are blamed for sins of commission, it is often the sins of omission that trip up users even more.
Consider the case of Lynne Chauvin, who worked as a medical assistant at Ochsner Health System, in Louisiana. In a still-pending 2015 lawsuit, Chauvin alleges that Epic’s software failed to fire a critical medication warning; Chauvin suffered from conditions that heightened her risk for blood clots, and though that history was documented in her records, she was treated with drugs that restricted blood flow after a heart procedure at the hospital. She developed gangrene, which led to the amputation of her lower legs and forearm. (Ochsner Health System said that while it cannot comment on ongoing litigation, it “remains committed to patient safety which we strongly believe is optimized through the use of electronic health record technology.” Epic declined to comment.)
Echoing the complaints of many doctors, the suit argues that Epic software “is extremely complicated to view and understand,” owing to “significant repetition of data.” Chauvin said that her medical bills have topped $1 million and that she is permanently disabled. Her husband, Richard, has become her primary caregiver and had to retire early from his job with the city of Kenner to care for his wife, according to the suit. Each party declined to comment.
An epidemic of burnout
The numbing repetition, the box-ticking and the endless searching on pulldown menus are all part of what Ratwani called the “cognitive burden” that’s wearing out today’s physicians and driving increasing numbers into early retirement.
In recent years, “physician burnout” has skyrocketed to the top of the agenda in medicine. A 2018 Merritt Hawkins survey found a staggering 78 percent of doctors suffered symptoms of burnout, and in January the Harvard School of Public Health and other institutions deemed it a “public health crisis.”
One of the co-authors of the Harvard study, Ashish Jha, pinned much of the blame on “the growth in poorly designed digital health records ... that [have] required that physicians spend more and more time on tasks that don’t directly benefit patients.”
Few would deny that the swift digitization of America’s medical system has been transformative. With EHRs now nearly universal, the face and feel of medicine has changed. The doctor is now typing away, making more eye contact with the computer screen, perhaps, than with the patient. Patients don’t like that dynamic; for doctors, whose days increasingly begin and end with such fleeting encounters, the effect can be downright deadening.
“You’re sitting in front of a patient, and there are so many things you have to do, and you only have so much time to do it in – seven to 11 minutes, probably – so when do you really listen?” asked John-Henry Pfifferling, a medical anthropologist who counsels physicians suffering from burnout. “If you go into medicine because you care about interacting, and then you’re just a tool, it’s dehumanizing,” said Pfifferling, who has seen many physicians leave medicine over the shift to electronic records. “It’s a disaster,” he said.
Beyond complicating the physician-patient relationship, EHRs have in some ways made practicing medicine harder, said Dr. Hal Baker, a physician and the chief information officer at WellSpan, a Pennsylvania hospital system. “Physicians have to cognitively switch between focusing on the record and focusing on the patient,” he said. He points out how unusual – and potentially dangerous – this is: “Texting while you’re driving is not a good idea. And I have yet to see the CEO who, while running a board meeting, takes minutes, and certainly I’ve never heard of a judge who, during the trial, would also be the court stenographer. But in medicine ... we’ve asked the physician to move from writing in pen to [entering a computer] record, and it’s a pretty complicated interface.”
Even if docs may be at the keyboard during visits, they report having to spend hours more outside that time – at lunch, late at night – in order to finish notes and keep up with electronic paperwork (sending referrals, corresponding with patients, resolving coding issues). That’s right. EHRs didn’t take away paperwork; the systems just moved it online. And there’s a lot of it: 44 percent of the roughly six hours a physician spends on the EHR each day is focused on clerical and administrative tasks, like billing and coding, according to a 2017 Annals of Family Medicine study.
For all that so-called pajama time – the average physician logs 1.4 hours per day on the EHR after work – they don’t get a cent.
Many doctors do recognize the value in the technology: 60 percent of participants in Stanford Medicine’s 2018 National Physician Poll said EHRs had led to improved patient care. At the same time, about as many (59 percent) said EHRs needed a “complete overhaul” and that the systems had detracted from their professional satisfaction (54 percent) as well as from their clinical effectiveness (49 percent).
In preliminary studies, Ratwani has found that doctors have a typical physiological reaction to using an EHR: stress. When he and his team shadow clinicians on the job, they use a range of sensors to monitor the doctors’ heart rate and other vital signs over the course of their shift. The physicians’ heart rates will spike – as high as 160 beats per minute – on two sorts of occasions: when they are interacting with patients and when they’re using the EHR.
4,000
Approximate number of computer clicks an ER doctor makes over the course of a single shift, according to an American Journal of Emergency Medicine study
“Everything is so cumbersome,” said Dr. Karla Dick, a family medicine physician in Arlington, Texas. “It’s slow compared to a paper chart. You’re having to click and zoom in and zoom out to look for stuff.” With all the zooming in and out, she explained, it’s easy to end up in the wrong record. “I can’t tell you how many times I’ve had to cancel an order because I was in the wrong chart.”
Among the daily frustrations for one emergency room physician in Rhode Island is ordering ibuprofen, a seemingly simple task that now requires many rounds of mouse clicking. Every time she prescribes the basic painkiller for a female patient, whether that patient is 9 or 68 years old, the prescription is blocked by a pop-up alert warning her that it may be dangerous to give the drug to a pregnant woman. The physician, whose institution does not allow her to comment on the systems, must then override the warning with yet more clicks. “That’s just the tiniest tip of the iceberg,” she said.
What worries the doctor most is the ease with which diligent, well-meaning physicians can make serious medical errors. She noted that the average ER doc will make 4,000 mouse clicks over the course of a shift, and that the odds of doing anything 4,000 times without an error is small. “The interfaces are just so confusing and clunky,” she added. “They invite error ... it’s not a negligence issue. This is a poor tool issue.”
Many of the EHR makers acknowledge physician burnout is real and say they’re doing what they can to lessen the burden and enhance user experience. Dr. Sam Butler, a pulmonary critical care specialist who started working at Epic in 2001, leads those efforts at the Wisconsin-based company. When doctors get more than 100 messages per week in their in-basket (akin to an email inbox), there’s a higher likelihood of burnout. Butler’s team has also analyzed doctors’ electronic notes – they’re twice as long as they were nine years ago, and three to four times as long as notes in the rest of the world. He said Epic uses such insights to improve the client experience. But coming up with fixes is difficult because doctors “have different viewpoints on everything,” he said. (KHN and Fortune made multiple requests to interview Epic CEO Judy Faulkner, but the company declined to make her available. In a trade interview in February, however, Faulkner said that EHRs were unfairly blamed for physician burnout and cited a study suggesting that there’s little correlation between burnout and EHR satisfaction. Executives at other vendors noted that they’re aware of usability issues and that they’re working on addressing them.)
“It’s not that we’re a bunch of Luddites who don’t know how to use technology,” said the Rhode Island ER doctor. “I have an iPhone and a computer and they work the way they’re supposed to work, and then we’re given these incredibly cumbersome and error-prone tools. This is something the government mandated. There really wasn’t the time to let the cream rise to the top; everyone had to jump in and pick something that worked and spend tens of millions of dollars on a system that is slowly killing us.”
$36 billion and change
The effort to digitize America’s health records got its biggest push in a very low moment: the financial crisis of 2008. In early December of that year, Obama, barely four weeks after his election, pitched an ambitious economic recovery plan. “We will make sure that every doctor’s office and hospital in this country is using cutting-edge technology and electronic medical records so that we can cut red tape, prevent medical mistakes and help save billions of dollars each year,” he said in a radio address.
The idea had already been a fashionable one in Washington. Former House Speaker Newt Gingrich was fond of saying it was easier to track a FedEx package than one’s medical records. Obama’s predecessor, President George W. Bush, had also pursued the idea of wiring up the country’s health system. He didn’t commit much money, but Bush did create an agency to do the job: the Office of the National Coordinator (ONC).
In the depths of recession, the EHR conceit looked like a shovel-ready project that only the paper lobby could hate. In February 2009, legislators passed the HITECH Act, which carved out a hefty chunk of the massive stimulus package for health information technology. The goal was not just to get hospitals and doctors to buy EHRs, but rather to get them using them in a way that would drive better care. So lawmakers devised a carrot-and-stick approach: Physicians would qualify for federal subsidies (a sum of up to nearly $64,000 over a period of years) only if they were “meaningful users” of a government-certified system. Vendors, for their part, had to develop systems that met the government’s requirements.
They didn’t have much time, though. The need to stimulate the economy, which meant getting providers to adopt EHRs quickly, “presented a tremendous conundrum,” said Farzad Mostashari, who joined the ONC as deputy director in 2009 and became its leader in 2011: The ideal – creating a useful, interoperable, nationwide records system – was “utterly infeasible to get to in a short time frame.”
That didn’t stop the federal planners from pursuing their grand ambitions. Everyone had big ideas for the EHRs. The FDA wanted the systems to track unique device identifiers for medical implants, the Centers for Disease Control and Prevention wanted them to support disease surveillance, CMS wanted them to include quality metrics and so on. “We had all the right ideas that were discussed and hashed out by the committee,” said Mostashari, “but they were all of the right ideas.”
Not everyone agreed, though, that they were the right ideas. Before long, “meaningful use” became pejorative shorthand to many for a burdensome government program – making doctors do things like check a box indicating a patient’s smoking status each and every visit.
The EHR vendor community, then a scrappy $2 billion industry, griped at the litany of requirements but stood to gain so much from the government’s $36 billion injection that it jumped in line. As Rusty Frantz, CEO of EHR vendor NextGen Healthcare, put it: “The industry was like, ‘I’ve got this check dangling in front of me, and I have to check these boxes to get there, and so I’m going to do that.’”
Halamka, who was an enthusiastic backer of the initiative in both the Bush and Obama administrations, blames the pressure for a speedy launch as much as the excessive wish list. “To go from a regulation to a highly usable product that is in the hands of doctors in 18 months, that’s too fast,” he said. “It’s like asking nine women to have a baby in a month.”
Several of those who worked on the project admit the rollout was not as easy or seamless as they’d anticipated, but they contend that was never the point. Aneesh Chopra, appointed by Obama in 2009 as the nation’s first chief technology officer, called the spending a “down payment” on a vision to fundamentally change American medicine – creating a digital infrastructure to support new ways to pay for health services based on their quality and outcomes.
Dr. Bob Kocher, a physician and star investor with venture capital firm Venrock, who served in the Obama administration from 2009 to 2011 as a health and economic policy adviser, not only defends the rollout then but also disputes the notion that the government initiative has been a failure at all. “EHRs have totally lived up to the hype and expectations,” he said, emphasizing that they also serve as a technology foundation to support innovation on everything from patients accessing their medical records on a smartphone to AI-driven medical sleuthing. Others note the systems’ value in aggregating medical data in ways that were never possible with paper – helping, for example, to figure out that contaminated water was poisoning children in Flint, Mich.
But Rusty Frantz heard a far different message about EHRs – and, more important, it was coming from his own customers.
The Stanford-trained engineer, who in 2015 became CEO of NextGen, a $500-million-a-year EHR heavyweight in the physician-office market, learned the hard way about how his product was being viewed. As he stood at the podium at his first meeting with thousands of NextGen customers at Las Vegas’ Mandalay Bay Resort, just four months after getting the job, he told KHN and Fortune, “People were lining up at the microphones to yell at us: ‘We weren’t delivering stable software! The executive team was inaccessible! The service experience was terrible!’ ” (He now refers to the event as “Festivus: the airing of the grievances.”)
Frantz had bounced around the health care industry for much of his career, and from the nearby perch of a medical device company, he watched the EHR incentive bonanza with a mix of envy and slack-jawed awe. “The industry was moving along in a natural Darwinist way, and then along came the stimulus,” said Frantz, who blames the government’s ham-handed approach to regulation. “The software got slammed in, and the software wasn’t implemented in a way that supported care,” he said. “It was installed in a way that supported stimulus. This company, we were complicit in it, too.”
Even that may be a generous description. KHN and Fortune found a trail of lawsuits against the company, stretching from White Sulphur Springs, Mont., to Neillsville, Wis. Mary Rutan Hospital in Bellefontaine, Ohio, sued NextGen (formerly called Quality Systems) in federal court in 2013, arguing that it experienced hundreds of problems with the “materially defective” software the company had installed in 2011.
A consultant hired by the hospital to evaluate the NextGen system, whose 60-page report was submitted to the court, identified “many functional defects” that he said rendered the software “unfit for its intended purpose.” Some patient information was not accurately recorded, which had the potential, the consultant wrote, “to create major patient care risk which could lead to, at a minimum, inconvenience, and at worst, malpractice or even death.” Glitches at Mary Rutan included incidents in which the software would apparently change a patient’s gender at random or lose a doctor’s observations after an exam, the consultant reported. The company, he found, sometimes took months to address issues: One IT ticket, which related to a physician’s notes inexplicably deleting themselves, reportedly took 10 months to resolve. (The consultant also noted that similar problems appeared to be occurring at as many as a dozen other hospitals that had installed NextGen software.)
The Ohio hospital, which paid more than $1.5 million for its EHR system, claimed breach of contract. NextGen responded that it disputed the claims made in the lawsuit and that the matter was resolved in 2015 “with no findings of fact by a court related to the allegations.” The hospital declined to comment.
At the time, as it has been since then, NextGen’s software was certified by the government as meeting the requirements of the stimulus program. By 2016, NextGen had more than 19,000 customers who had received federal subsidies.
NextGen was subpoenaed by the Department of Justice in December 2017, months after becoming the subject of a federal investigation led by the District of Vermont. Frantz tells KHN and Fortune that NextGen is cooperating with the investigation. “This company was not dishonest, but it was not effective four years ago,” he said. Frantz also emphasized that NextGen has “rapidly evolved” during his tenure, earning five industry awards since 2017, and that customers have “responded very positively.”
Glen Tullman, who until 2012 led Allscripts, another leading EHR vendor that benefited royally from the stimulus and that has been sued by numerous unhappy customers, admitted that the industry’s race to market took priority over all else.
“It was a big distraction. That was an unintended consequence of that,” Tullman said. “All the companies were saying, This is a one-time opportunity to expand our share, focus everything there, and then we’ll go back and fix it.” The Justice Department has opened a civil investigation into the company, Securities and Exchange Commission filings show. Allscripts said in an email that it cannot comment on an ongoing investigation, but that the civil investigations by the Department of Justice relate to businesses it acquired after the investigations were opened.
Much of the marketing mayhem occurred because federal officials imposed few controls over firms scrambling to cash in on the stimulus. It was a gold rush – and any system, it seemed, could be marketed as “federally approved.” Doctors could shop for bargain-price software packages at Costco and Walmart’s Sam’s Club – where eClinicalWorks sold a “turnkey” system for $11,925 – and cash in on the government’s adoption incentives.
The top-shelf vendors in 2009 crisscrossed the country on a “stimulus tour” like rock groups, gigging at some 30 cities, where they offered doctors who showed up to hear the pitch “a customized analysis” of how much money they could earn off the government incentives. Following the same playbook used by pharmaceutical companies, EHR sellers courted doctors at fancy dinners in ritzy hotels. One enterprising software firm advertised a “cash for clunkers” deal that paid $3,000 to doctors willing to trade in their current records system for a new one. Athenahealth held “invitation only” dinners at luxury hotels to advise doctors, among other things, how to use the stimulus to get paid more and capture available incentives. Allscripts offered a no-money-down purchase plan to help doctors “maximize the return on your EHR investment.” (An Athenahealth spokesperson said the company’s “dinners were educational in nature and aimed at helping physicians navigate the government program.” Allscripts did not respond directly to questions about its marketing practices, but said it “is proud of the software and services [it provides] to hundreds of thousands of caregivers across the globe.”)
EHRs were supposed to reduce health care costs, at least in part by preventing duplicative tests. But as the federal government opened the stimulus tap, many raised doubts about the promised savings. Advocates bandied about a figure of $80 billion in cost savings even as congressional auditors were debunking it. While the jury’s still out, there’s growing suspicion the digital revolution may potentially raise health care costs by encouraging overbilling and new strains of fraud and abuse.
In September 2012, following press reports suggesting that some doctors and hospitals were using the new technology to improperly boost their fees, a practice known as “upcoding,” then-Health and Human Services chief Kathleen Sebelius and Attorney General Eric Holder warned the industry not to try to “game the system.”
There’s also growing evidence that some doctors and health systems may have overstated their use of the new technology to secure stimulus funds, a potentially enormous fraud against Medicare and Medicaid that likely will take many years to unravel. In June 2017, the HHS inspector general estimated that Medicare officials made more than $729 million in subsidy payments to hospitals and doctors that didn’t deserve them.
Individual states, which administer the Medicaid portion of the program, haven’t fared much better. Audits have uncovered overpayments in 14 of 17 state programs reviewed, totaling more than $66 million, according to inspector general reports.
Last month, Sen. Chuck Grassley, an Iowa Republican who chairs the Senate Finance Committee, sharply criticized CMS for recovering only a tiny fraction of these bogus payments, or what he termed a “spit in the ocean.”
EHR vendors have also been accused of egregious and patient-endangering acts of fraud as they raced to cash in on the stimulus money grab. In addition to the U.S. government’s $155 million False Claims Act settlement with eClinicalWorks noted above, the federal government has reached a second settlement over similar charges against another large vendor, Tampa-based Greenway Health. In February, that company settled with the government for just over $57 million without denying or admitting wrongdoing. “These are cases of corporate greed, companies that prioritized profits over everything else,” said Christina Nolan, the U.S. attorney for the District of Vermont, whose office led the cases. (In a response, Greenway Health did not address the charges or the settlement but said it was “committing itself to being the standard-bearer for quality, compliance, and transparency.”)
Tower of Babel
In early 2017, Seema Verma, then the country’s newly appointed CMS administrator, went on a listening tour. She visited doctors around the country, at big urban practices and tiny rural clinics, and from those front-line physicians she consistently heard one thing: They hated their electronic health records. “Physician burnout is real,” she told KHN and Fortune. The doctors spoke of the difficulty in getting information from other systems and providers, and they complained about the government’s reporting requirements, which they perceived as burdensome and not meaningful.
What she heard then became suddenly personal one summer day in 2017, when her husband, himself a physician, collapsed in the airport on his way home to Indianapolis after a family vacation. For a frantic few hours, the CMS administrator fielded phone calls from first responders and physicians – Did she know his medical history? Did she have information that could save his life? – and made calls to his doctors in Indiana, scrambling to piece together his record, which should have been there in one piece. Her husband survived the episode, but it laid bare the dysfunction and danger inherent in the existing health information ecosystem.
The notion that one EHR should talk to another was a key part of the original vision for the HITECH Act, with the government calling for systems to be eventually interoperable.
What the framers of that vision didn’t count on were the business incentives working against it. A free exchange of information means that patients can be treated anywhere. And though they may not admit it, many health providers are loath to lose their patients to a competing doctor’s office or hospital. There’s a term for that lost revenue: “leakage.” And keeping a tight hold on patients’ medical records is one way to prevent it.
There’s a ton of proprietary value in that data, said Blumenthal, who now heads the Commonwealth Fund, a philanthropy that does health research. Asking hospitals to give it up is “like asking Amazon to share their data with Walmart,” he said.
Blumenthal acknowledged that he failed to grasp these perverse business dynamics and foresee what a challenge getting the systems to talk to one another would be. He added that forcing interoperability goals early on, when 90 percent of the nation’s providers still didn’t have systems or data to exchange, seemed unrealistic. “We had an expression: They had to operate before they could interoperate,” he said.
In the absence of true incentives for systems to communicate, the industry limped along; some providers wired up directly to other select providers or through regional exchanges, but the efforts were spotty. A Cerner-backed interoperability network called CommonWell formed in 2013, but some companies, including dominant Epic, didn’t join. (“Initially, Epic was neither invited nor allowed to join,” said Sumit Rana, senior vice president of R&D at Epic. Jitin Asnaani, executive director of CommonWell countered, “We made repeated invitations to every major EHR ... and numerous public and private invitations to Epic.”)
Epic then supported a separate effort to do much the same.
Last spring, Verma attempted to kick-start the sharing effort and later pledged a war on “information blocking,” threatening penalties for bad actors. She has promised to reduce the documentation burden on physicians and end the gag clauses that protect the EHR industry. Regarding the first effort at least, “there was consensus that this needed to happen and that it would take the government to push this forward,” she said. In one sign of progress last summer, the dueling sharing initiatives of Epic and Cerner, the two largest players in the industry, began to share with each other – though the effort is fledgling.
When it comes to patients, though, the real sharing too often stops. Despite federal requirements that providers give patients their medical records in a timely fashion, in their chosen format and at low cost (the government recommends a flat fee of $6.50 or less), patients struggle mightily to get them. A 2017 study by researchers at Yale found that of America’s 83 top-rated hospitals, only 53 percent offer forms that provide patients with the option to receive their entire medical record. Fewer than half would share records via email. One hospital charged more than $500 to release them.
Sometimes the mere effort to access records leads to court. Jennifer De Angelis, a Tulsa attorney, has frequently sparred with hospitals over releasing her clients’ records. She said they either attempt to charge huge sums for them or force her to obtain a court order before releasing them. De Angelis added that she sometimes suspects the records have been overwritten to cover up medical mistakes.
Consider the case of 5-year-old Uriah R. Roach, who fractured and cut his finger on Oct. 2, 2014, when it was accidentally slammed in a door at school. Five days later, an operation to repair the damage went awry, and he suffered permanent brain damage, apparently owing to an anesthesia problem. The Epic electronic medical file had been accessed more than 76,000 times during the 22 days the boy was in the hospital, and a lawsuit brought by his parents contended that numerous entries had been “corrected, altered, modified and possibly deleted after an unexpected outcome during the induction of anesthesia.” The hospital denied wrongdoing. The case settled in November 2016, and the terms are confidential.
More than a dozen other attorneys interviewed cited similar problems, especially with gaining access to computerized “audit trails.” In several cases, court records show, government lawyers resisted turning over electronic files from federally run hospitals. That happened to Russell Uselton, an Oklahoma lawyer who represented a pregnant teen admitted to the Choctaw Nation Health Care Center in Talihina, Okla. Shelby Carshall, 18, was more than 40 weeks pregnant at the time. Doctors failed to perform a cesarean section, and her baby was born brain-damaged as a result, she alleged in a lawsuit filed in 2017 against the U.S. government. The baby began having seizures at 10 hours old and will “likely never walk, talk, eat, or otherwise live normally,” according to pleadings in the suit. Though the federal government requires hospitals to produce electronic health records to patients and their families, Uselton had to obtain a court order to get the baby’s complete medical files. Government lawyers denied any negligence in the case, which is pending.
“They try to hide anything from you that they can hide from you,” said Uselton. “They make it extremely difficult to get records, so expensive and hard that most lawyers can’t take it on,” he said.
Nor, it seems, can high-ranking federal officials. When Seema Verma’s husband was discharged from the hospital after his summer health scare, he was handed a few papers and a CD-ROM containing some medical images – but missing key tests and monitoring data. Said Verma, “We left that hospital and we still don’t have his information today.” That was nearly two years ago
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.
The pain radiated from the top of Annette Monachelli’s head, and it got worse when she changed positions. It didn’t feel like her usual migraine. The 47-year-old Vermont attorney turned innkeeper visited her local doctor at the Stowe Family Practice twice about the problem in late November 2012, but got little relief.
Two months later, Monachelli was dead of an aneurysm, a condition that, despite the symptoms and the appointments, had never been tested for or diagnosed until she turned up in the emergency room days before her death.
Monachelli’s husband sued Stowe, the federally qualified health center the physician worked for. Owen Foster, a newly hired assistant U.S. attorney with the District of Vermont, was assigned to defend the government. Though it looked to be a standard medical malpractice case, Foster was on the cusp of discovering something much bigger – what his boss, U.S. Attorney Christina Nolan, calls the “frontier of health care fraud” – and prosecuting a first-of-its-kind case that landed the largest-ever financial recovery in Vermont’s history.
Foster began with Monachelli’s medical records, which offered a puzzle. Her doctor had considered the possibility of an aneurysm and, to rule it out, had ordered a head scan through the clinic’s software system, the government alleged in court filings. The test, in theory, would have caught the bleeding in Monachelli’s brain. But the order never made it to the lab; it had never been transmitted.
The software in question was an electronic health records system, or EHR, made by eClinicalWorks (eCW), one of the leading sellers of record-keeping software for physicians in America, currently used by 850,000 health professionals in the U.S. It didn’t take long for Foster to assemble a dossier of troubling reports – Better Business Bureau complaints, issues flagged on an eCW user board, and legal cases filed around the country – suggesting the company’s technology didn’t work quite the way it said it did.
Until this point, Foster, like most Americans, knew next to nothing about electronic medical records, but he was quickly amassing clues that eCW’s software had major problems – some of which put patients, like Annette Monachelli, at risk.
Damning evidence came from a whistleblower claim filed in 2011 against the company. Brendan Delaney, a British cop turned EHR expert, was hired in 2010 by New York City to work on the eCW implementation at Rikers Island, a jail complex that then had more than 100,000 inmates. But soon after he was hired, Delaney noticed scores of troubling problems with the system, which became the basis for his lawsuit. The patient medication lists weren’t reliable; prescribed drugs would not show up, while discontinued drugs would appear as current, according to the complaint. The EHR would sometimes display one patient’s medication profile accompanied by the physician’s note for a different patient, making it easy to misdiagnose or prescribe a drug to the wrong individual. Prescriptions, some 30,000 of them in 2010, lacked proper start and stop dates, introducing the opportunity for under- or overmedication. The eCW system did not reliably track lab results, concluded Delaney, who tallied 1,884 tests for which they had never gotten outcomes.
The District of Vermont launched an official federal investigation in 2015.
The eCW spaghetti code was so buggy that when one glitch got fixed, another would develop, the government found. The user interface offered a few ways to order a lab test or diagnostic image, for example, but not all of them seemed to function. The software would detect and warn users of dangerous drug interactions, but unbeknownst to physicians, the alerts stopped if the drug order was customized. “It would be like if I was driving with the radio on and the windshield wipers going and when I hit the turn signal, the brakes suddenly didn’t work,” said Foster.
The eCW system also failed to use the standard drug codes and, in some instances, lab and diagnosis codes as well, the government alleged.
The case never got to a jury. In May 2017, eCW paid a $155 million settlement to the government over alleged “false claims” and kickbacks – one physician made tens of thousands of dollars – to clients who promoted its product. Despite the record settlement, the company denied wrongdoing; eCW did not respond to numerous requests for comment.
If there is a kicker to this tale, it is this: The U.S. government bankrolled the adoption of this software – and continues to pay for it. Or we should say: You do.
Which brings us to the strange, sad, and aggravating story that unfolds below. It is not about one lawsuit or a piece of sloppy technology. Rather, it’s about a trouble-prone industry that intersects, in the most personal way, with every one of our lives. It’s about a $3.7 trillion health care system idling at the crossroads of progress. And it’s about a slew of unintended consequences – the surprising casualties of a big idea whose time had seemingly come.
The virtual magic bullet
Electronic health records were supposed to do a lot: make medicine safer, bring higher-quality care, empower patients, and yes, even save money. Boosters heralded an age when researchers could harness the big data within to reveal the most effective treatments for disease and sharply reduce medical errors. Patients, in turn, would have truly portable health records, being able to share their medical histories in a flash with doctors and hospitals anywhere in the country – essential when life-and-death decisions are being made in the ER.
But 10 years after President Barack Obama signed a law to accelerate the digitization of medical records – with the federal government, so far, sinking $36 billion into the effort – America has little to show for its investment. KHN and Fortune spoke with more than 100 physicians, patients, IT experts and administrators, health policy leaders, attorneys, top government officials and representatives at more than a half-dozen EHR vendors, including the CEOs of two of the companies. The interviews reveal a tragic missed opportunity: Rather than an electronic ecosystem of information, the nation’s thousands of EHRs largely remain a sprawling, disconnected patchwork. Moreover, the effort has handcuffed health providers to technology they mostly can’t stand and has enriched and empowered the $13-billion-a-year industry that sells it.
By one measure, certainly, the effort has achieved what it set out to do: Today, 96% of hospitals have adopted EHRs, up from just 9% in 2008. But on most other counts, the newly installed technology has fallen well short. Physicians complain about clumsy, unintuitive systems and the number of hours spent clicking, typing and trying to navigate them – which is more than the hours they spend with patients. Unlike, say, with the global network of ATMs, the proprietary EHR systems made by more than 700 vendors routinely don’t talk to one another, meaning that doctors still resort to transferring medical data via fax and CD-ROM. Patients, meanwhile, still struggle to access their own records – and, sometimes, just plain can’t.
Instead of reducing costs, many say, EHRs, which were originally optimized for billing rather than for patient care, have instead made it easier to engage in “upcoding” or bill inflation (though some say the systems also make such fraud easier to catch).
More gravely still, a months-long joint investigation by KHN and Fortune has found that instead of streamlining medicine, the government’s EHR initiative has created a host of largely unacknowledged patient safety risks. Our investigation found that alarming reports of patient deaths, serious injuries and near misses – thousands of them – tied to software glitches, user errors or other flaws have piled up, largely unseen, in various government-funded and private repositories.
Compounding the problem are entrenched secrecy policies that continue to keep software failures out of public view. EHR vendors often impose contractual “gag clauses” that discourage buyers from speaking out about safety issues and disastrous software installations – though some customers have taken to the courts to air their grievances. Plaintiffs, moreover, say hospitals often fight to withhold records from injured patients or their families. Indeed, two doctors who spoke candidly about the problems they faced with EHRs later asked that their names not be used, adding that they were forbidden by their health care organizations to talk. Says Assistant U.S. Attorney Foster, the EHR vendors “are protected by a shield of silence.”
Though the software has reduced some types of clinical mistakes common in the era of handwritten notes, Raj Ratwani, a researcher at MedStar Health in Washington, D.C., has documented new patterns of medical errors tied to EHRs that he believes are both perilous and preventable. “The fact that we’re not able to broadcast that nationally and solve these issues immediately, and that another patient somewhere else may be harmed by the very same issue – that just can’t happen,” he said.
David Blumenthal, who, as Obama’s national coordinator for health information technology, was one of the architects of the EHR initiative, acknowledged to KHN and Fortune that electronic health records “have not fulfilled their potential. I think few would argue they have.”
The former president has likewise singled out the effort as one of his most disappointing, bemoaning in a January 2017 interview with Vox “the fact that there are still just mountains of paperwork ... and the doctors still have to input stuff, and the nurses are spending all their time on all this administrative work. We put a big slug of money into trying to encourage everyone to digitalize, to catch up with the rest of the world ... that’s been harder than we expected.”
Seema Verma, the current chief of the Centers for Medicare & Medicaid Services (CMS), which oversees the EHR effort today, shudders at the billions of dollars spent building software that doesn’t share data – an electronic bridge to nowhere. “Providers developed their own systems that may or may not even have worked well for them,” she told KHN and Fortune in an interview last month, “but we didn’t think about how all these systems connect with one another. That was the real missing piece.”
Perhaps none of the initiative’s former boosters is quite as frustrated as former Vice President Joe Biden. At a 2017 meeting with health care leaders in Washington, he railed against the infuriating challenge of getting his son Beau’s medical records from one hospital to another. “I was stunned when my son for a year was battling stage 4 glioblastoma,” said Biden. “I couldn’t get his records. I’m the vice president of the United States of America. ... It was an absolute nightmare. It was ridiculous, absolutely ridiculous, that we’re in that circumstance.”
A bridge to nowhere
As Biden would tell you, the original concept was a smart one. The wave of digitization had swept up virtually every industry, bringing both disruption and, in most cases, greater efficiency. And perhaps none of these industries was more deserving of digital liberation than medicine, where life-measuring and potentially lifesaving data was locked away in paper crypts – stack upon stack of file folders at doctors’ offices across the country.
Stowed in steel cabinets, the records were next to useless. Nobody – particularly at the dawn of the age of the iPhone – thought it was a good idea to leave them that way. The problem, say critics, was in the way that policymakers set about to transform them.
“Every single idea was well-meaning and potentially of societal benefit, but the combined burden of all of them hitting clinicians simultaneously made office practice basically impossible,” said John Halamka, chief information officer at Beth Israel Deaconess Medical Center, who served on the EHR standards committees under both President George W. Bush and President Obama. “In America, we have 11 minutes to see a patient, and, you know, you’re going to be empathetic, make eye contact, enter about 100 pieces of data, and never commit malpractice. It’s not possible!”
KHN and Fortune examined more than two dozen medical negligence cases that have alleged that EHRs either contributed to injuries, had been improperly altered, or were withheld from patients to conceal substandard care. In such cases, the suits typically settle prior to trial with strict confidentiality pledges, so it’s often not possible to determine the merits of the allegations. EHR vendors also frequently have contract stipulations, known as “hold harmless clauses,” that protect them from liability if hospitals are later sued for medical errors – even if they relate to an issue with the technology.
But lawsuits, like that filed by Fabian Ronisky, which do emerge from this veil, are quite telling.
Ronisky, according to his complaint, arrived by ambulance at Providence Saint John’s Health Center in Santa Monica on the afternoon of March 2, 2015. For two days, the young lawyer had been suffering from severe headaches while a disorienting fever left him struggling to tell the 911 operator his address.
Suspecting meningitis, a doctor at the hospital performed a spinal tap, and the next day an infectious disease specialist typed in an order for a critical lab test – a check of the spinal fluid for viruses, including herpes simplex – into the hospital’s EHR.
The multimillion-dollar system, manufactured by Epic Systems Corp. and considered by some to be the Cadillac of medical software, had been installed at the hospital about four months earlier. Although the order appeared on Epic’s screen, it was not sent to the lab. It turned out, Epic’s software didn’t fully “interface” with the lab’s software, according to a lawsuit Ronisky filed in February 2017 in Los Angeles County Superior Court. His results and diagnosis were delayed – by days, he claimed – during which time he suffered irreversible brain damage from herpes encephalitis. The suit alleged the mishap delayed doctors from giving Ronisky a drug called acyclovir that might have minimized damage to his brain.
Epic denied any liability or defects in its software; the company said the doctor failed to push the right button to send the order and that the hospital, not Epic, had configured the interface with the lab. Epic, among the nation’s largest manufacturers of computerized health records and the leading provider to most of America’s most elite medical centers, quietly paid $1 million to settle the suit in July 2018, according to court records. The hospital and two doctors paid a total of $7.5 million, and a case against a third doctor is pending trial. Ronisky, 34, who is fighting to rebuild his life, declined to comment.
Incidents like that which happened to Ronisky – or to Annette Monachelli, for that matter – are surprisingly common, data show. And the back-and-forth about where the fault lies in such cases is actually part of the problem: The systems are often so confusing (and training on them seldom sufficient) that errors frequently fall into a nether zone of responsibility. It can be hard to tell where human error begins and the technological shortcomings end.
EHRs promised to put all of a patient’s records in one place, but often that’s the problem. Critical or time-sensitive information routinely gets buried in an endless scroll of data, where in the rush of medical decision-making – and amid the maze of pulldown menus – it can be missed.
Thirteen-year-old Brooke Dilliplaine, who was severely allergic to dairy, was given a probiotic containing milk. The two doses sent her into “complete respiratory distress” and resulted in a collapsed lung, according to a lawsuit filed by her mother. Rory Staunton, 12, scraped his arm in gym class and then died of sepsis after ER doctors discharged the boy on the basis of lab results in the EHR that weren’t complete. And then there’s the case of Thomas Eric Duncan. The 42-year-old man was sent home in 2014 from a Dallas hospital infected with Ebola virus. Though a nurse had entered in the EHR his recent travel to Liberia, where an Ebola epidemic was then in full swing, the doctor never saw it. Duncan died a week later.
Many such cases end up in court. Typically, doctors and nurses blame faulty technology in the medical-records systems. The EHR vendors blame human error. And meanwhile, the cases mount.
Quantros, a private health care analytics firm, said it has logged 18,000 EHR-related safety events from 2007 through 2018, 3 percent of which resulted in patient harm, including seven deaths – a figure that a Quantros director said is “drastically underreported.”
A 2016 study by The Leapfrog Group, a patient-safety watchdog based in Washington, D.C., found that the medication-ordering function of hospital EHRs – a feature required by the government for certification but often configured differently in each system – failed to flag potentially harmful drug orders in 39 percent of cases in a test simulation. In 13 percent of those cases, the mistake could have been fatal
The Pew Charitable Trusts has, for the past few years, run an EHR safety project, taking aim at issues like usability and patient matching – the process of linking the correct medical record to the correct patient – a seemingly basic task at which the systems, even when made by the same EHR vendor, often fail. At some institutions, according to Pew, such matching was accurate only 50 percent of the time. Patients have discovered mistakes as well: A January survey by the Kaiser Family Foundation found that 1 in 5 patients spotted an error in their electronic medical records. (Kaiser Health News is an editorially independent program of the foundation.)
The Joint Commission, which certifies hospitals, has sounded alarms about a number of issues, including false alarms – which account for between 85 and 99 percent of EHR and medical device alerts. (One study by researchers at Oregon Health & Science University estimated that the average clinician working in the intensive care unit may be exposed to up to 7,000 passive alerts per day.) Such over-warning can be dangerous. From 2014 to 2018, the commission tallied 170 mostly voluntary reports of patient harm related to alarm management and alert fatigue – the phenomenon in which health workers, so overloaded with unnecessary warnings, ignore the occasional meaningful one. Of those 170 incidents, 101 resulted in patient deaths.
The Pennsylvania Patient Safety Authority, an independent state agency that collects information about adverse events and incidents, counted 775 “laboratory-test problems” related to health IT from January 2016 to December 2017.
To be sure, medical errors happened en masse in the age of paper medicine, when hospital staffers misinterpreted a physician’s scrawl or read the wrong chart to deadly consequence, for instance. But what is perhaps telling is how many doctors today opt for manual workarounds to their EHRs. Aaron Zachary Hettinger, an emergency medicine physician with MedStar Health in Washington, D.C., said that when he and fellow clinicians need to share critical patient information, they write it on a whiteboard or on a paper towel and leave it on their colleagues’ computer keyboards.
While the Food and Drug Administration doesn’t mandate reporting of EHR safety events – as it does for regulated medical devices – concerned posts have nonetheless proliferated in the FDA MAUDE database of adverse events, which now serves as an ad hoc bulletin board of warnings about the various systems.
Further complicating the picture is that health providers nearly always tailor their one-size-fits-all EHR systems to their own specifications. Such customization makes every one unique and often hard to compare with others – which, in turn, makes the source of mistakes difficult to determine.
Dr. Martin Makary, a surgical oncologist at Johns Hopkins and the co-author of a much-cited 2016 study that identified medical errors as the third-leading cause of death in America, credits EHRs for some safety improvements – including recent changes that have helped put electronic brakes on the opioid epidemic. But, he said, “we’ve swapped one set of problems for another. We used to struggle with handwriting and missing information. We now struggle with a lack of visual cues to know we’re writing and ordering on the correct patient.”
Dr. Joseph Schneider, a pediatrician at UT Southwestern Medical Center, compares the transition we’ve made, from paper records to electronic ones, to moving from horses to automobiles. But in this analogy, he added, “our cars have advanced to about the 1960s. They still don’t have seat belts or air bags.”
Schneider recalled one episode when his colleagues couldn’t understand why chunks of their notes would inexplicably disappear. They figured out the problem weeks later after intense study: Physicians had been inputting squiggly brackets – {} – the use of which, unbeknownst to even vendor representatives, deleted the text between them. (The EHR maker initially blamed the doctors, said Schneider.)
A broad coalition of actors, from National Nurses United to the Texas Medical Association to leaders within the FDA, has long called for oversight on electronic-record safety issues. Among the most outspoken is Ratwani, who directs MedStar Health’s National Center on Human Factors in Healthcare, a 30-person institute focused on optimizing the safety and usability of medical technology. Ratwani spent his early career in the defense industry, studying things like the intuitiveness of information displays. When he got to MedStar in 2012, he was stunned by “the types of [digital] interfaces being used” in health care, he said.
In a study published last year in the journal Health Affairs, Ratwani and colleagues studied medication errors at three pediatric hospitals from 2012 to 2017. They discovered that 3,243 of them were owing in part to EHR “usability issues.” Roughly 1 in 5 of these could have resulted in patient harm, the researchers found. “Poor interface design and poor implementations can lead to errors and sometimes death, and that is just unbelievably bad as well as completely fixable,” he said. “We should not have patients harmed this way.”
Using eye-tracking technology, Ratwani has demonstrated on video just how easy it is to make mistakes when performing basic tasks on the nation’s two leading EHR systems. When emergency room doctors went to order Tylenol, for example, they saw a drop-down menu listing 86 options, many of which were irrelevant for the specified patient. They had to read the list carefully, so as not to click the wrong dosage or form – though many do that too: In roughly 1 out of 1,000 orders, physicians accidentally select the suppository (designated “PR”) rather than the tablet dose (“OR”), according to one estimate. That’s not an error that will harm a patient – though other medication mix-ups can and do.
Earlier this year, MedStar’s human-factors center launched a website and public awareness campaign with the American Medical Association to draw attention to such rampant mistakes – they use the letters “EHR” as an initialism for “Errors Happen Regularly” – and to petition Congress for action. Ratwani is pushing for a central database to track such errors and adverse events.
Others have turned to social media to vent. Dr. Mark Friedberg, a health-policy researcher with the Rand Corp. who is also a practicing primary care physician, champions the Twitter hashtag #EHRbuglist to encourage fellow health care workers to air their pain points. And last month, a scathing Epic parody account cropped up on Twitter, earning more than 8,000 followers in its first five days. Its maiden tweet, written in the mock voice of an Epic overlord, read: “I once saw a doctor make eye contact with a patient. This horror must stop.”
As much as EHR systems are blamed for sins of commission, it is often the sins of omission that trip up users even more.
Consider the case of Lynne Chauvin, who worked as a medical assistant at Ochsner Health System, in Louisiana. In a still-pending 2015 lawsuit, Chauvin alleges that Epic’s software failed to fire a critical medication warning; Chauvin suffered from conditions that heightened her risk for blood clots, and though that history was documented in her records, she was treated with drugs that restricted blood flow after a heart procedure at the hospital. She developed gangrene, which led to the amputation of her lower legs and forearm. (Ochsner Health System said that while it cannot comment on ongoing litigation, it “remains committed to patient safety which we strongly believe is optimized through the use of electronic health record technology.” Epic declined to comment.)
Echoing the complaints of many doctors, the suit argues that Epic software “is extremely complicated to view and understand,” owing to “significant repetition of data.” Chauvin said that her medical bills have topped $1 million and that she is permanently disabled. Her husband, Richard, has become her primary caregiver and had to retire early from his job with the city of Kenner to care for his wife, according to the suit. Each party declined to comment.
An epidemic of burnout
The numbing repetition, the box-ticking and the endless searching on pulldown menus are all part of what Ratwani called the “cognitive burden” that’s wearing out today’s physicians and driving increasing numbers into early retirement.
In recent years, “physician burnout” has skyrocketed to the top of the agenda in medicine. A 2018 Merritt Hawkins survey found a staggering 78 percent of doctors suffered symptoms of burnout, and in January the Harvard School of Public Health and other institutions deemed it a “public health crisis.”
One of the co-authors of the Harvard study, Ashish Jha, pinned much of the blame on “the growth in poorly designed digital health records ... that [have] required that physicians spend more and more time on tasks that don’t directly benefit patients.”
Few would deny that the swift digitization of America’s medical system has been transformative. With EHRs now nearly universal, the face and feel of medicine has changed. The doctor is now typing away, making more eye contact with the computer screen, perhaps, than with the patient. Patients don’t like that dynamic; for doctors, whose days increasingly begin and end with such fleeting encounters, the effect can be downright deadening.
“You’re sitting in front of a patient, and there are so many things you have to do, and you only have so much time to do it in – seven to 11 minutes, probably – so when do you really listen?” asked John-Henry Pfifferling, a medical anthropologist who counsels physicians suffering from burnout. “If you go into medicine because you care about interacting, and then you’re just a tool, it’s dehumanizing,” said Pfifferling, who has seen many physicians leave medicine over the shift to electronic records. “It’s a disaster,” he said.
Beyond complicating the physician-patient relationship, EHRs have in some ways made practicing medicine harder, said Dr. Hal Baker, a physician and the chief information officer at WellSpan, a Pennsylvania hospital system. “Physicians have to cognitively switch between focusing on the record and focusing on the patient,” he said. He points out how unusual – and potentially dangerous – this is: “Texting while you’re driving is not a good idea. And I have yet to see the CEO who, while running a board meeting, takes minutes, and certainly I’ve never heard of a judge who, during the trial, would also be the court stenographer. But in medicine ... we’ve asked the physician to move from writing in pen to [entering a computer] record, and it’s a pretty complicated interface.”
Even if docs may be at the keyboard during visits, they report having to spend hours more outside that time – at lunch, late at night – in order to finish notes and keep up with electronic paperwork (sending referrals, corresponding with patients, resolving coding issues). That’s right. EHRs didn’t take away paperwork; the systems just moved it online. And there’s a lot of it: 44 percent of the roughly six hours a physician spends on the EHR each day is focused on clerical and administrative tasks, like billing and coding, according to a 2017 Annals of Family Medicine study.
For all that so-called pajama time – the average physician logs 1.4 hours per day on the EHR after work – they don’t get a cent.
Many doctors do recognize the value in the technology: 60 percent of participants in Stanford Medicine’s 2018 National Physician Poll said EHRs had led to improved patient care. At the same time, about as many (59 percent) said EHRs needed a “complete overhaul” and that the systems had detracted from their professional satisfaction (54 percent) as well as from their clinical effectiveness (49 percent).
In preliminary studies, Ratwani has found that doctors have a typical physiological reaction to using an EHR: stress. When he and his team shadow clinicians on the job, they use a range of sensors to monitor the doctors’ heart rate and other vital signs over the course of their shift. The physicians’ heart rates will spike – as high as 160 beats per minute – on two sorts of occasions: when they are interacting with patients and when they’re using the EHR.
4,000
Approximate number of computer clicks an ER doctor makes over the course of a single shift, according to an American Journal of Emergency Medicine study
“Everything is so cumbersome,” said Dr. Karla Dick, a family medicine physician in Arlington, Texas. “It’s slow compared to a paper chart. You’re having to click and zoom in and zoom out to look for stuff.” With all the zooming in and out, she explained, it’s easy to end up in the wrong record. “I can’t tell you how many times I’ve had to cancel an order because I was in the wrong chart.”
Among the daily frustrations for one emergency room physician in Rhode Island is ordering ibuprofen, a seemingly simple task that now requires many rounds of mouse clicking. Every time she prescribes the basic painkiller for a female patient, whether that patient is 9 or 68 years old, the prescription is blocked by a pop-up alert warning her that it may be dangerous to give the drug to a pregnant woman. The physician, whose institution does not allow her to comment on the systems, must then override the warning with yet more clicks. “That’s just the tiniest tip of the iceberg,” she said.
What worries the doctor most is the ease with which diligent, well-meaning physicians can make serious medical errors. She noted that the average ER doc will make 4,000 mouse clicks over the course of a shift, and that the odds of doing anything 4,000 times without an error is small. “The interfaces are just so confusing and clunky,” she added. “They invite error ... it’s not a negligence issue. This is a poor tool issue.”
Many of the EHR makers acknowledge physician burnout is real and say they’re doing what they can to lessen the burden and enhance user experience. Dr. Sam Butler, a pulmonary critical care specialist who started working at Epic in 2001, leads those efforts at the Wisconsin-based company. When doctors get more than 100 messages per week in their in-basket (akin to an email inbox), there’s a higher likelihood of burnout. Butler’s team has also analyzed doctors’ electronic notes – they’re twice as long as they were nine years ago, and three to four times as long as notes in the rest of the world. He said Epic uses such insights to improve the client experience. But coming up with fixes is difficult because doctors “have different viewpoints on everything,” he said. (KHN and Fortune made multiple requests to interview Epic CEO Judy Faulkner, but the company declined to make her available. In a trade interview in February, however, Faulkner said that EHRs were unfairly blamed for physician burnout and cited a study suggesting that there’s little correlation between burnout and EHR satisfaction. Executives at other vendors noted that they’re aware of usability issues and that they’re working on addressing them.)
“It’s not that we’re a bunch of Luddites who don’t know how to use technology,” said the Rhode Island ER doctor. “I have an iPhone and a computer and they work the way they’re supposed to work, and then we’re given these incredibly cumbersome and error-prone tools. This is something the government mandated. There really wasn’t the time to let the cream rise to the top; everyone had to jump in and pick something that worked and spend tens of millions of dollars on a system that is slowly killing us.”
$36 billion and change
The effort to digitize America’s health records got its biggest push in a very low moment: the financial crisis of 2008. In early December of that year, Obama, barely four weeks after his election, pitched an ambitious economic recovery plan. “We will make sure that every doctor’s office and hospital in this country is using cutting-edge technology and electronic medical records so that we can cut red tape, prevent medical mistakes and help save billions of dollars each year,” he said in a radio address.
The idea had already been a fashionable one in Washington. Former House Speaker Newt Gingrich was fond of saying it was easier to track a FedEx package than one’s medical records. Obama’s predecessor, President George W. Bush, had also pursued the idea of wiring up the country’s health system. He didn’t commit much money, but Bush did create an agency to do the job: the Office of the National Coordinator (ONC).
In the depths of recession, the EHR conceit looked like a shovel-ready project that only the paper lobby could hate. In February 2009, legislators passed the HITECH Act, which carved out a hefty chunk of the massive stimulus package for health information technology. The goal was not just to get hospitals and doctors to buy EHRs, but rather to get them using them in a way that would drive better care. So lawmakers devised a carrot-and-stick approach: Physicians would qualify for federal subsidies (a sum of up to nearly $64,000 over a period of years) only if they were “meaningful users” of a government-certified system. Vendors, for their part, had to develop systems that met the government’s requirements.
They didn’t have much time, though. The need to stimulate the economy, which meant getting providers to adopt EHRs quickly, “presented a tremendous conundrum,” said Farzad Mostashari, who joined the ONC as deputy director in 2009 and became its leader in 2011: The ideal – creating a useful, interoperable, nationwide records system – was “utterly infeasible to get to in a short time frame.”
That didn’t stop the federal planners from pursuing their grand ambitions. Everyone had big ideas for the EHRs. The FDA wanted the systems to track unique device identifiers for medical implants, the Centers for Disease Control and Prevention wanted them to support disease surveillance, CMS wanted them to include quality metrics and so on. “We had all the right ideas that were discussed and hashed out by the committee,” said Mostashari, “but they were all of the right ideas.”
Not everyone agreed, though, that they were the right ideas. Before long, “meaningful use” became pejorative shorthand to many for a burdensome government program – making doctors do things like check a box indicating a patient’s smoking status each and every visit.
The EHR vendor community, then a scrappy $2 billion industry, griped at the litany of requirements but stood to gain so much from the government’s $36 billion injection that it jumped in line. As Rusty Frantz, CEO of EHR vendor NextGen Healthcare, put it: “The industry was like, ‘I’ve got this check dangling in front of me, and I have to check these boxes to get there, and so I’m going to do that.’”
Halamka, who was an enthusiastic backer of the initiative in both the Bush and Obama administrations, blames the pressure for a speedy launch as much as the excessive wish list. “To go from a regulation to a highly usable product that is in the hands of doctors in 18 months, that’s too fast,” he said. “It’s like asking nine women to have a baby in a month.”
Several of those who worked on the project admit the rollout was not as easy or seamless as they’d anticipated, but they contend that was never the point. Aneesh Chopra, appointed by Obama in 2009 as the nation’s first chief technology officer, called the spending a “down payment” on a vision to fundamentally change American medicine – creating a digital infrastructure to support new ways to pay for health services based on their quality and outcomes.
Dr. Bob Kocher, a physician and star investor with venture capital firm Venrock, who served in the Obama administration from 2009 to 2011 as a health and economic policy adviser, not only defends the rollout then but also disputes the notion that the government initiative has been a failure at all. “EHRs have totally lived up to the hype and expectations,” he said, emphasizing that they also serve as a technology foundation to support innovation on everything from patients accessing their medical records on a smartphone to AI-driven medical sleuthing. Others note the systems’ value in aggregating medical data in ways that were never possible with paper – helping, for example, to figure out that contaminated water was poisoning children in Flint, Mich.
But Rusty Frantz heard a far different message about EHRs – and, more important, it was coming from his own customers.
The Stanford-trained engineer, who in 2015 became CEO of NextGen, a $500-million-a-year EHR heavyweight in the physician-office market, learned the hard way about how his product was being viewed. As he stood at the podium at his first meeting with thousands of NextGen customers at Las Vegas’ Mandalay Bay Resort, just four months after getting the job, he told KHN and Fortune, “People were lining up at the microphones to yell at us: ‘We weren’t delivering stable software! The executive team was inaccessible! The service experience was terrible!’ ” (He now refers to the event as “Festivus: the airing of the grievances.”)
Frantz had bounced around the health care industry for much of his career, and from the nearby perch of a medical device company, he watched the EHR incentive bonanza with a mix of envy and slack-jawed awe. “The industry was moving along in a natural Darwinist way, and then along came the stimulus,” said Frantz, who blames the government’s ham-handed approach to regulation. “The software got slammed in, and the software wasn’t implemented in a way that supported care,” he said. “It was installed in a way that supported stimulus. This company, we were complicit in it, too.”
Even that may be a generous description. KHN and Fortune found a trail of lawsuits against the company, stretching from White Sulphur Springs, Mont., to Neillsville, Wis. Mary Rutan Hospital in Bellefontaine, Ohio, sued NextGen (formerly called Quality Systems) in federal court in 2013, arguing that it experienced hundreds of problems with the “materially defective” software the company had installed in 2011.
A consultant hired by the hospital to evaluate the NextGen system, whose 60-page report was submitted to the court, identified “many functional defects” that he said rendered the software “unfit for its intended purpose.” Some patient information was not accurately recorded, which had the potential, the consultant wrote, “to create major patient care risk which could lead to, at a minimum, inconvenience, and at worst, malpractice or even death.” Glitches at Mary Rutan included incidents in which the software would apparently change a patient’s gender at random or lose a doctor’s observations after an exam, the consultant reported. The company, he found, sometimes took months to address issues: One IT ticket, which related to a physician’s notes inexplicably deleting themselves, reportedly took 10 months to resolve. (The consultant also noted that similar problems appeared to be occurring at as many as a dozen other hospitals that had installed NextGen software.)
The Ohio hospital, which paid more than $1.5 million for its EHR system, claimed breach of contract. NextGen responded that it disputed the claims made in the lawsuit and that the matter was resolved in 2015 “with no findings of fact by a court related to the allegations.” The hospital declined to comment.
At the time, as it has been since then, NextGen’s software was certified by the government as meeting the requirements of the stimulus program. By 2016, NextGen had more than 19,000 customers who had received federal subsidies.
NextGen was subpoenaed by the Department of Justice in December 2017, months after becoming the subject of a federal investigation led by the District of Vermont. Frantz tells KHN and Fortune that NextGen is cooperating with the investigation. “This company was not dishonest, but it was not effective four years ago,” he said. Frantz also emphasized that NextGen has “rapidly evolved” during his tenure, earning five industry awards since 2017, and that customers have “responded very positively.”
Glen Tullman, who until 2012 led Allscripts, another leading EHR vendor that benefited royally from the stimulus and that has been sued by numerous unhappy customers, admitted that the industry’s race to market took priority over all else.
“It was a big distraction. That was an unintended consequence of that,” Tullman said. “All the companies were saying, This is a one-time opportunity to expand our share, focus everything there, and then we’ll go back and fix it.” The Justice Department has opened a civil investigation into the company, Securities and Exchange Commission filings show. Allscripts said in an email that it cannot comment on an ongoing investigation, but that the civil investigations by the Department of Justice relate to businesses it acquired after the investigations were opened.
Much of the marketing mayhem occurred because federal officials imposed few controls over firms scrambling to cash in on the stimulus. It was a gold rush – and any system, it seemed, could be marketed as “federally approved.” Doctors could shop for bargain-price software packages at Costco and Walmart’s Sam’s Club – where eClinicalWorks sold a “turnkey” system for $11,925 – and cash in on the government’s adoption incentives.
The top-shelf vendors in 2009 crisscrossed the country on a “stimulus tour” like rock groups, gigging at some 30 cities, where they offered doctors who showed up to hear the pitch “a customized analysis” of how much money they could earn off the government incentives. Following the same playbook used by pharmaceutical companies, EHR sellers courted doctors at fancy dinners in ritzy hotels. One enterprising software firm advertised a “cash for clunkers” deal that paid $3,000 to doctors willing to trade in their current records system for a new one. Athenahealth held “invitation only” dinners at luxury hotels to advise doctors, among other things, how to use the stimulus to get paid more and capture available incentives. Allscripts offered a no-money-down purchase plan to help doctors “maximize the return on your EHR investment.” (An Athenahealth spokesperson said the company’s “dinners were educational in nature and aimed at helping physicians navigate the government program.” Allscripts did not respond directly to questions about its marketing practices, but said it “is proud of the software and services [it provides] to hundreds of thousands of caregivers across the globe.”)
EHRs were supposed to reduce health care costs, at least in part by preventing duplicative tests. But as the federal government opened the stimulus tap, many raised doubts about the promised savings. Advocates bandied about a figure of $80 billion in cost savings even as congressional auditors were debunking it. While the jury’s still out, there’s growing suspicion the digital revolution may potentially raise health care costs by encouraging overbilling and new strains of fraud and abuse.
In September 2012, following press reports suggesting that some doctors and hospitals were using the new technology to improperly boost their fees, a practice known as “upcoding,” then-Health and Human Services chief Kathleen Sebelius and Attorney General Eric Holder warned the industry not to try to “game the system.”
There’s also growing evidence that some doctors and health systems may have overstated their use of the new technology to secure stimulus funds, a potentially enormous fraud against Medicare and Medicaid that likely will take many years to unravel. In June 2017, the HHS inspector general estimated that Medicare officials made more than $729 million in subsidy payments to hospitals and doctors that didn’t deserve them.
Individual states, which administer the Medicaid portion of the program, haven’t fared much better. Audits have uncovered overpayments in 14 of 17 state programs reviewed, totaling more than $66 million, according to inspector general reports.
Last month, Sen. Chuck Grassley, an Iowa Republican who chairs the Senate Finance Committee, sharply criticized CMS for recovering only a tiny fraction of these bogus payments, or what he termed a “spit in the ocean.”
EHR vendors have also been accused of egregious and patient-endangering acts of fraud as they raced to cash in on the stimulus money grab. In addition to the U.S. government’s $155 million False Claims Act settlement with eClinicalWorks noted above, the federal government has reached a second settlement over similar charges against another large vendor, Tampa-based Greenway Health. In February, that company settled with the government for just over $57 million without denying or admitting wrongdoing. “These are cases of corporate greed, companies that prioritized profits over everything else,” said Christina Nolan, the U.S. attorney for the District of Vermont, whose office led the cases. (In a response, Greenway Health did not address the charges or the settlement but said it was “committing itself to being the standard-bearer for quality, compliance, and transparency.”)
Tower of Babel
In early 2017, Seema Verma, then the country’s newly appointed CMS administrator, went on a listening tour. She visited doctors around the country, at big urban practices and tiny rural clinics, and from those front-line physicians she consistently heard one thing: They hated their electronic health records. “Physician burnout is real,” she told KHN and Fortune. The doctors spoke of the difficulty in getting information from other systems and providers, and they complained about the government’s reporting requirements, which they perceived as burdensome and not meaningful.
What she heard then became suddenly personal one summer day in 2017, when her husband, himself a physician, collapsed in the airport on his way home to Indianapolis after a family vacation. For a frantic few hours, the CMS administrator fielded phone calls from first responders and physicians – Did she know his medical history? Did she have information that could save his life? – and made calls to his doctors in Indiana, scrambling to piece together his record, which should have been there in one piece. Her husband survived the episode, but it laid bare the dysfunction and danger inherent in the existing health information ecosystem.
The notion that one EHR should talk to another was a key part of the original vision for the HITECH Act, with the government calling for systems to be eventually interoperable.
What the framers of that vision didn’t count on were the business incentives working against it. A free exchange of information means that patients can be treated anywhere. And though they may not admit it, many health providers are loath to lose their patients to a competing doctor’s office or hospital. There’s a term for that lost revenue: “leakage.” And keeping a tight hold on patients’ medical records is one way to prevent it.
There’s a ton of proprietary value in that data, said Blumenthal, who now heads the Commonwealth Fund, a philanthropy that does health research. Asking hospitals to give it up is “like asking Amazon to share their data with Walmart,” he said.
Blumenthal acknowledged that he failed to grasp these perverse business dynamics and foresee what a challenge getting the systems to talk to one another would be. He added that forcing interoperability goals early on, when 90 percent of the nation’s providers still didn’t have systems or data to exchange, seemed unrealistic. “We had an expression: They had to operate before they could interoperate,” he said.
In the absence of true incentives for systems to communicate, the industry limped along; some providers wired up directly to other select providers or through regional exchanges, but the efforts were spotty. A Cerner-backed interoperability network called CommonWell formed in 2013, but some companies, including dominant Epic, didn’t join. (“Initially, Epic was neither invited nor allowed to join,” said Sumit Rana, senior vice president of R&D at Epic. Jitin Asnaani, executive director of CommonWell countered, “We made repeated invitations to every major EHR ... and numerous public and private invitations to Epic.”)
Epic then supported a separate effort to do much the same.
Last spring, Verma attempted to kick-start the sharing effort and later pledged a war on “information blocking,” threatening penalties for bad actors. She has promised to reduce the documentation burden on physicians and end the gag clauses that protect the EHR industry. Regarding the first effort at least, “there was consensus that this needed to happen and that it would take the government to push this forward,” she said. In one sign of progress last summer, the dueling sharing initiatives of Epic and Cerner, the two largest players in the industry, began to share with each other – though the effort is fledgling.
When it comes to patients, though, the real sharing too often stops. Despite federal requirements that providers give patients their medical records in a timely fashion, in their chosen format and at low cost (the government recommends a flat fee of $6.50 or less), patients struggle mightily to get them. A 2017 study by researchers at Yale found that of America’s 83 top-rated hospitals, only 53 percent offer forms that provide patients with the option to receive their entire medical record. Fewer than half would share records via email. One hospital charged more than $500 to release them.
Sometimes the mere effort to access records leads to court. Jennifer De Angelis, a Tulsa attorney, has frequently sparred with hospitals over releasing her clients’ records. She said they either attempt to charge huge sums for them or force her to obtain a court order before releasing them. De Angelis added that she sometimes suspects the records have been overwritten to cover up medical mistakes.
Consider the case of 5-year-old Uriah R. Roach, who fractured and cut his finger on Oct. 2, 2014, when it was accidentally slammed in a door at school. Five days later, an operation to repair the damage went awry, and he suffered permanent brain damage, apparently owing to an anesthesia problem. The Epic electronic medical file had been accessed more than 76,000 times during the 22 days the boy was in the hospital, and a lawsuit brought by his parents contended that numerous entries had been “corrected, altered, modified and possibly deleted after an unexpected outcome during the induction of anesthesia.” The hospital denied wrongdoing. The case settled in November 2016, and the terms are confidential.
More than a dozen other attorneys interviewed cited similar problems, especially with gaining access to computerized “audit trails.” In several cases, court records show, government lawyers resisted turning over electronic files from federally run hospitals. That happened to Russell Uselton, an Oklahoma lawyer who represented a pregnant teen admitted to the Choctaw Nation Health Care Center in Talihina, Okla. Shelby Carshall, 18, was more than 40 weeks pregnant at the time. Doctors failed to perform a cesarean section, and her baby was born brain-damaged as a result, she alleged in a lawsuit filed in 2017 against the U.S. government. The baby began having seizures at 10 hours old and will “likely never walk, talk, eat, or otherwise live normally,” according to pleadings in the suit. Though the federal government requires hospitals to produce electronic health records to patients and their families, Uselton had to obtain a court order to get the baby’s complete medical files. Government lawyers denied any negligence in the case, which is pending.
“They try to hide anything from you that they can hide from you,” said Uselton. “They make it extremely difficult to get records, so expensive and hard that most lawyers can’t take it on,” he said.
Nor, it seems, can high-ranking federal officials. When Seema Verma’s husband was discharged from the hospital after his summer health scare, he was handed a few papers and a CD-ROM containing some medical images – but missing key tests and monitoring data. Said Verma, “We left that hospital and we still don’t have his information today.” That was nearly two years ago
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.
Geriatric assessments could fine-tune cancer care for older adults
Fewer than 25% of older cancer patients currently get these assessments, which evaluate a person’s functioning (what he can and cannot do), psychological status, nutrition, cognition, social circumstances, and other, coexisting medical conditions, and which can predict the potential toxicity of chemotherapy.
The new guideline, ASCO’s first in the field of “geriatric oncology,” may have significant potential to change medical practice. “These recommendations will capture the attention of oncologists, I think, and that will be incredibly valuable,” said Corinne Leach, PhD, strategic director of cancer and aging research at the American Cancer Society.
They recognize a shifting demographic reality for cancer specialists, who are treating increasingly older patients as life spans lengthen across the globe. In the United States, 60% of patients newly diagnosed with cancer (an estimated 1.7 million people this year) are aged 65 years or older, as are more than 60% of cancer survivors.
Yet evidence about how best to treat older adults with cancer is weak because older adults are underrepresented in clinical trials. And most oncologists have received little training in how to manage older patients’ unique vulnerabilities.
When researchers asked 305 community oncologists about evaluating older patients, 89% acknowledged “the care of older adults with cancer needs to be improved,” according to a recently published study. Fewer than 25% said they were “very confident” they could identify dementia or accurately assess a patient’s functioning or risk of falling – factors associated with poorer outcomes for cancer treatment.
Still, resistance to change is evident. “We’re all inundated with trying to keep up with new standards of care, and I doubt there will be any broad acceptance of the rigor called for in this guideline,” said Frederick Schnell, MD, medical director of the Community Oncology Alliance.
The burden on physicians shouldn’t be significant, however: The streamlined assessments recommended in the ASCO guideline take only about 20 minutes to complete. Patients fill out surveys during most of that time; about five minutes is required for a nurse or physician assistant to administer several brief tests.
The assessment can identify people at increased risk of experiencing serious side effects from chemotherapy – infections, fatigue, diarrhea, dehydration and other problems that affect more than half of older patients. Physicians can then take steps to address these vulnerabilities, such as prescribing physical therapy for an older patient with muscle weakness or ordering a nutritional consultation for someone who has become malnourished. Also, they can alter chemotherapy regimens to minimize the potential for harm.
Currently, most oncologists decide whether older patients can benefit from chemotherapy by using the “eyeball test,” an assessment that relies primarily on their experience and judgment. “This isn’t enough to understand factors that put older adults at risk; it takes a deeper dive,” said Arti Hurria, MD, director of the Center for Cancer and Aging and professor of medical oncology and therapeutics research at City of Hope, a comprehensive cancer center in Duarte, Calif., and cochair of the panel that produced the new guidelines.
An oncologist walking into a room in a busy clinic might find an older patient already on the exam table, for instance, and miss the fact that he needed assistance getting out of a chair and getting into a gown – important signs of functional impairment that could be aggravated by chemotherapy, Dr. Hurria said. Or, “a very pleasant older patient might smile kindly at you and agree with everything you’re saying, and she might not have understood a thing you said” because of undetected cognitive impairment that could worsen and interfere with treatment, she explained.
William Dale, MD, a geriatrician and Arthur M. Coppola Family Chair in Supportive Care Medicine at City of Hope and another cochair of the guideline panel, tells of an 83-year-old woman whom he saw several years ago, with lung cancer metastasized to her brain. Her family requested a consultation because she’d become withdrawn and forgetful – a sign of accelerating cognitive impairment, they suspected.
Should she have chemotherapy and whole brain radiation, or would that worsen her memory lapses, the patient and family wondered?
One result stood out when Dale ordered a geriatric assessment: This older woman wasn’t cognitively impaired, she was psychologically distressed. “She wasn’t eating, she wasn’t interacting with other people, she appeared not to want treatment, but all this was due to depression,” Dr. Dale recalled. With counseling, the patient decided to undergo chemotherapy and radiation treatment, which he called “remarkably successful.”
Just as genetic tests are being used to personalize care for older cancer patients, geriatric assessments can be employed for this purpose – at considerably less expense, said Supriya Gupta Mohile, MD, editor in chief of the Journal of Geriatric Oncology and director of geriatric oncology at the James Wilmot Cancer Institute at the University of Rochester (N.Y.).
She tells of a 78-year-old man with invasive bladder cancer who came in for a consultation. From the medical chart, she learned the patient had hypertension, diabetes, and depression, all reasonably well controlled. From a geriatric assessment, she discovered that he lived alone, had cognitive impairment, relied on his daughter to deliver meals, and was at high risk of falling.
“The patient and his daughter were worried about his safety at home, his cognition getting worse, and fatigue [he was dealing with] and how that might affect his ability to function,” Dr. Mohile said. “His goal was to stay independent, at home, and not be hospitalized or go to rehabilitation.”
The standard of care for this condition was 3-4 months of chemotherapy before surgery, but Dr. Mohile recommended that the older patient skip chemotherapy and have surgery immediately, after reviewing the geriatric assessment with her patient and his family.
Every older patient considering chemotherapy should request an evaluation of this kind, even if your physician doesn’t offer it, said Heidi D. Klepin, MD, associate professor of hematology and oncology at Wake Forest University, Winston-Salem, N.C. “Ask for your doctor to consider your ability to do the things you most care about doing and for care to be individualized to your unique circumstances.”
KHN’s coverage of these topics is supported by John A. Hartford Foundation, Gordon and Betty Moore Foundation, and The SCAN Foundation. 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.
Fewer than 25% of older cancer patients currently get these assessments, which evaluate a person’s functioning (what he can and cannot do), psychological status, nutrition, cognition, social circumstances, and other, coexisting medical conditions, and which can predict the potential toxicity of chemotherapy.
The new guideline, ASCO’s first in the field of “geriatric oncology,” may have significant potential to change medical practice. “These recommendations will capture the attention of oncologists, I think, and that will be incredibly valuable,” said Corinne Leach, PhD, strategic director of cancer and aging research at the American Cancer Society.
They recognize a shifting demographic reality for cancer specialists, who are treating increasingly older patients as life spans lengthen across the globe. In the United States, 60% of patients newly diagnosed with cancer (an estimated 1.7 million people this year) are aged 65 years or older, as are more than 60% of cancer survivors.
Yet evidence about how best to treat older adults with cancer is weak because older adults are underrepresented in clinical trials. And most oncologists have received little training in how to manage older patients’ unique vulnerabilities.
When researchers asked 305 community oncologists about evaluating older patients, 89% acknowledged “the care of older adults with cancer needs to be improved,” according to a recently published study. Fewer than 25% said they were “very confident” they could identify dementia or accurately assess a patient’s functioning or risk of falling – factors associated with poorer outcomes for cancer treatment.
Still, resistance to change is evident. “We’re all inundated with trying to keep up with new standards of care, and I doubt there will be any broad acceptance of the rigor called for in this guideline,” said Frederick Schnell, MD, medical director of the Community Oncology Alliance.
The burden on physicians shouldn’t be significant, however: The streamlined assessments recommended in the ASCO guideline take only about 20 minutes to complete. Patients fill out surveys during most of that time; about five minutes is required for a nurse or physician assistant to administer several brief tests.
The assessment can identify people at increased risk of experiencing serious side effects from chemotherapy – infections, fatigue, diarrhea, dehydration and other problems that affect more than half of older patients. Physicians can then take steps to address these vulnerabilities, such as prescribing physical therapy for an older patient with muscle weakness or ordering a nutritional consultation for someone who has become malnourished. Also, they can alter chemotherapy regimens to minimize the potential for harm.
Currently, most oncologists decide whether older patients can benefit from chemotherapy by using the “eyeball test,” an assessment that relies primarily on their experience and judgment. “This isn’t enough to understand factors that put older adults at risk; it takes a deeper dive,” said Arti Hurria, MD, director of the Center for Cancer and Aging and professor of medical oncology and therapeutics research at City of Hope, a comprehensive cancer center in Duarte, Calif., and cochair of the panel that produced the new guidelines.
An oncologist walking into a room in a busy clinic might find an older patient already on the exam table, for instance, and miss the fact that he needed assistance getting out of a chair and getting into a gown – important signs of functional impairment that could be aggravated by chemotherapy, Dr. Hurria said. Or, “a very pleasant older patient might smile kindly at you and agree with everything you’re saying, and she might not have understood a thing you said” because of undetected cognitive impairment that could worsen and interfere with treatment, she explained.
William Dale, MD, a geriatrician and Arthur M. Coppola Family Chair in Supportive Care Medicine at City of Hope and another cochair of the guideline panel, tells of an 83-year-old woman whom he saw several years ago, with lung cancer metastasized to her brain. Her family requested a consultation because she’d become withdrawn and forgetful – a sign of accelerating cognitive impairment, they suspected.
Should she have chemotherapy and whole brain radiation, or would that worsen her memory lapses, the patient and family wondered?
One result stood out when Dale ordered a geriatric assessment: This older woman wasn’t cognitively impaired, she was psychologically distressed. “She wasn’t eating, she wasn’t interacting with other people, she appeared not to want treatment, but all this was due to depression,” Dr. Dale recalled. With counseling, the patient decided to undergo chemotherapy and radiation treatment, which he called “remarkably successful.”
Just as genetic tests are being used to personalize care for older cancer patients, geriatric assessments can be employed for this purpose – at considerably less expense, said Supriya Gupta Mohile, MD, editor in chief of the Journal of Geriatric Oncology and director of geriatric oncology at the James Wilmot Cancer Institute at the University of Rochester (N.Y.).
She tells of a 78-year-old man with invasive bladder cancer who came in for a consultation. From the medical chart, she learned the patient had hypertension, diabetes, and depression, all reasonably well controlled. From a geriatric assessment, she discovered that he lived alone, had cognitive impairment, relied on his daughter to deliver meals, and was at high risk of falling.
“The patient and his daughter were worried about his safety at home, his cognition getting worse, and fatigue [he was dealing with] and how that might affect his ability to function,” Dr. Mohile said. “His goal was to stay independent, at home, and not be hospitalized or go to rehabilitation.”
The standard of care for this condition was 3-4 months of chemotherapy before surgery, but Dr. Mohile recommended that the older patient skip chemotherapy and have surgery immediately, after reviewing the geriatric assessment with her patient and his family.
Every older patient considering chemotherapy should request an evaluation of this kind, even if your physician doesn’t offer it, said Heidi D. Klepin, MD, associate professor of hematology and oncology at Wake Forest University, Winston-Salem, N.C. “Ask for your doctor to consider your ability to do the things you most care about doing and for care to be individualized to your unique circumstances.”
KHN’s coverage of these topics is supported by John A. Hartford Foundation, Gordon and Betty Moore Foundation, and The SCAN Foundation. 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.
Fewer than 25% of older cancer patients currently get these assessments, which evaluate a person’s functioning (what he can and cannot do), psychological status, nutrition, cognition, social circumstances, and other, coexisting medical conditions, and which can predict the potential toxicity of chemotherapy.
The new guideline, ASCO’s first in the field of “geriatric oncology,” may have significant potential to change medical practice. “These recommendations will capture the attention of oncologists, I think, and that will be incredibly valuable,” said Corinne Leach, PhD, strategic director of cancer and aging research at the American Cancer Society.
They recognize a shifting demographic reality for cancer specialists, who are treating increasingly older patients as life spans lengthen across the globe. In the United States, 60% of patients newly diagnosed with cancer (an estimated 1.7 million people this year) are aged 65 years or older, as are more than 60% of cancer survivors.
Yet evidence about how best to treat older adults with cancer is weak because older adults are underrepresented in clinical trials. And most oncologists have received little training in how to manage older patients’ unique vulnerabilities.
When researchers asked 305 community oncologists about evaluating older patients, 89% acknowledged “the care of older adults with cancer needs to be improved,” according to a recently published study. Fewer than 25% said they were “very confident” they could identify dementia or accurately assess a patient’s functioning or risk of falling – factors associated with poorer outcomes for cancer treatment.
Still, resistance to change is evident. “We’re all inundated with trying to keep up with new standards of care, and I doubt there will be any broad acceptance of the rigor called for in this guideline,” said Frederick Schnell, MD, medical director of the Community Oncology Alliance.
The burden on physicians shouldn’t be significant, however: The streamlined assessments recommended in the ASCO guideline take only about 20 minutes to complete. Patients fill out surveys during most of that time; about five minutes is required for a nurse or physician assistant to administer several brief tests.
The assessment can identify people at increased risk of experiencing serious side effects from chemotherapy – infections, fatigue, diarrhea, dehydration and other problems that affect more than half of older patients. Physicians can then take steps to address these vulnerabilities, such as prescribing physical therapy for an older patient with muscle weakness or ordering a nutritional consultation for someone who has become malnourished. Also, they can alter chemotherapy regimens to minimize the potential for harm.
Currently, most oncologists decide whether older patients can benefit from chemotherapy by using the “eyeball test,” an assessment that relies primarily on their experience and judgment. “This isn’t enough to understand factors that put older adults at risk; it takes a deeper dive,” said Arti Hurria, MD, director of the Center for Cancer and Aging and professor of medical oncology and therapeutics research at City of Hope, a comprehensive cancer center in Duarte, Calif., and cochair of the panel that produced the new guidelines.
An oncologist walking into a room in a busy clinic might find an older patient already on the exam table, for instance, and miss the fact that he needed assistance getting out of a chair and getting into a gown – important signs of functional impairment that could be aggravated by chemotherapy, Dr. Hurria said. Or, “a very pleasant older patient might smile kindly at you and agree with everything you’re saying, and she might not have understood a thing you said” because of undetected cognitive impairment that could worsen and interfere with treatment, she explained.
William Dale, MD, a geriatrician and Arthur M. Coppola Family Chair in Supportive Care Medicine at City of Hope and another cochair of the guideline panel, tells of an 83-year-old woman whom he saw several years ago, with lung cancer metastasized to her brain. Her family requested a consultation because she’d become withdrawn and forgetful – a sign of accelerating cognitive impairment, they suspected.
Should she have chemotherapy and whole brain radiation, or would that worsen her memory lapses, the patient and family wondered?
One result stood out when Dale ordered a geriatric assessment: This older woman wasn’t cognitively impaired, she was psychologically distressed. “She wasn’t eating, she wasn’t interacting with other people, she appeared not to want treatment, but all this was due to depression,” Dr. Dale recalled. With counseling, the patient decided to undergo chemotherapy and radiation treatment, which he called “remarkably successful.”
Just as genetic tests are being used to personalize care for older cancer patients, geriatric assessments can be employed for this purpose – at considerably less expense, said Supriya Gupta Mohile, MD, editor in chief of the Journal of Geriatric Oncology and director of geriatric oncology at the James Wilmot Cancer Institute at the University of Rochester (N.Y.).
She tells of a 78-year-old man with invasive bladder cancer who came in for a consultation. From the medical chart, she learned the patient had hypertension, diabetes, and depression, all reasonably well controlled. From a geriatric assessment, she discovered that he lived alone, had cognitive impairment, relied on his daughter to deliver meals, and was at high risk of falling.
“The patient and his daughter were worried about his safety at home, his cognition getting worse, and fatigue [he was dealing with] and how that might affect his ability to function,” Dr. Mohile said. “His goal was to stay independent, at home, and not be hospitalized or go to rehabilitation.”
The standard of care for this condition was 3-4 months of chemotherapy before surgery, but Dr. Mohile recommended that the older patient skip chemotherapy and have surgery immediately, after reviewing the geriatric assessment with her patient and his family.
Every older patient considering chemotherapy should request an evaluation of this kind, even if your physician doesn’t offer it, said Heidi D. Klepin, MD, associate professor of hematology and oncology at Wake Forest University, Winston-Salem, N.C. “Ask for your doctor to consider your ability to do the things you most care about doing and for care to be individualized to your unique circumstances.”
KHN’s coverage of these topics is supported by John A. Hartford Foundation, Gordon and Betty Moore Foundation, and The SCAN Foundation. 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.
Looking for lower Medicare drug costs? Ask your pharmacist for the cash price
As part of President Donald Trump’s blueprint to bring down prescription costs, Medicare officials have warned insurers that “gag orders” keeping pharmacists from alerting seniors that they could save money by paying cash – rather than using their insurance – are “unacceptable and contrary” to the government’s effort to promote price transparency.
But the agency stopped short of requiring insurers to lift such restrictions on pharmacists.
That doesn’t mean people with Medicare drug coverage are destined to overpay for prescriptions. But first, they must ask the pharmacist about that option, said Julie Carter, federal policy associate at the Medicare Rights Center, a patient advocacy group.
“If they bring it up, then we can inform them of those prices,” said Nick Newman, PharmD, a pharmacist and the manager at Essentra Pharmacy in rural Marengo, Ohio. “It’s a moral dilemma for the pharmacist, knowing what would be best for the patient, but not being able to help them and hoping they will ask you about the comparison.”
A simple question could unlock some savings for millions of beneficiaries.
But details may be hard to find: Medicare’s website and annual handbook don’t mention it.
“If you don’t know that there are a bunch of different prices that could be available at any given pharmacy, you don’t know what you don’t know,” said Leigh Purvis, the AARP Public Policy Institute’s director of health services research.
Researchers analyzing 9.5 million Part D prescription claims reported in a letter in the Journal of the American Medical Association in March that a patient’s copayment was higher than the cash price for nearly one in four drugs purchased in 2013. For 12 of the 20 most commonly prescribed drugs, patients overpaid by more than 33%.
Although the study found that the average overpayment for a single prescription was relatively small, Dr. Newman said he had seen consumers pay as much as $30 more than the cash price.
And many beneficiaries may not know that, if they pay a lower cash price for a covered drug at a pharmacy that participates in their insurance plan and then submit the proper documentation, insurers must count it toward their out-of-pocket expenses. The total of those expenses can trigger the drug coverage gap, commonly called the doughnut hole. (This year, the gap begins after the plan and beneficiary spend $3,750 and ends once the beneficiary has spent a total of $5,000.)
Daniel Nam, executive director of federal programs at America’s Health Insurance Plans, a trade group, agreed that “patients should have access to the lowest price possible at the pharmacy.” But he said Medicare’s warning, contained in a letter in May 2018, takes aim at an increasingly rare occurrence. Gag order clauses are “not something they are incorporating into their contracts,” he said.
UnitedHealthcare, whose popular prescription drug plans dominate the market, does not include them in any of its Medicare, Medicaid, or commercial insurance contracts, said Matt Burns, a company spokesman.
Pharmacy benefit managers also said gag orders are not typical. “If it is happening, it is very much an outlier,” said Mark Merritt, president and CEO of the Pharmaceutical Care Management Association.
However, some pharmacists disagree. Kala Shankle, policy and regulatory affairs director for the National Community Pharmacists Association, which represents 22,000 independent pharmacies, said insurers have punished pharmacists who violate gag orders by dropping them from the plan’s network.
In Ohio, one of several states that have banned gag orders in insurance contracts, including some Medicare drug plans, officials responded to complaints about the problem.
“The Department has received inquiries related to entities withholding cost-saving information from consumers, which sometimes results in an insured [patient] paying more for pharmacy benefits than the actual cost of such pharmacy benefits,” the department said in April.
Illinois and Ohio state legislators are considering bills to make such restrictions illegal, and similar legislation has been introduced in the U.S. Senate.
“If we didn’t have these gag clauses, there would not be a need for the legislation and policy changes movement that’s going on in the country,” said Garth Reynolds, executive director of the Illinois Pharmacists Association.
KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. 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.
As part of President Donald Trump’s blueprint to bring down prescription costs, Medicare officials have warned insurers that “gag orders” keeping pharmacists from alerting seniors that they could save money by paying cash – rather than using their insurance – are “unacceptable and contrary” to the government’s effort to promote price transparency.
But the agency stopped short of requiring insurers to lift such restrictions on pharmacists.
That doesn’t mean people with Medicare drug coverage are destined to overpay for prescriptions. But first, they must ask the pharmacist about that option, said Julie Carter, federal policy associate at the Medicare Rights Center, a patient advocacy group.
“If they bring it up, then we can inform them of those prices,” said Nick Newman, PharmD, a pharmacist and the manager at Essentra Pharmacy in rural Marengo, Ohio. “It’s a moral dilemma for the pharmacist, knowing what would be best for the patient, but not being able to help them and hoping they will ask you about the comparison.”
A simple question could unlock some savings for millions of beneficiaries.
But details may be hard to find: Medicare’s website and annual handbook don’t mention it.
“If you don’t know that there are a bunch of different prices that could be available at any given pharmacy, you don’t know what you don’t know,” said Leigh Purvis, the AARP Public Policy Institute’s director of health services research.
Researchers analyzing 9.5 million Part D prescription claims reported in a letter in the Journal of the American Medical Association in March that a patient’s copayment was higher than the cash price for nearly one in four drugs purchased in 2013. For 12 of the 20 most commonly prescribed drugs, patients overpaid by more than 33%.
Although the study found that the average overpayment for a single prescription was relatively small, Dr. Newman said he had seen consumers pay as much as $30 more than the cash price.
And many beneficiaries may not know that, if they pay a lower cash price for a covered drug at a pharmacy that participates in their insurance plan and then submit the proper documentation, insurers must count it toward their out-of-pocket expenses. The total of those expenses can trigger the drug coverage gap, commonly called the doughnut hole. (This year, the gap begins after the plan and beneficiary spend $3,750 and ends once the beneficiary has spent a total of $5,000.)
Daniel Nam, executive director of federal programs at America’s Health Insurance Plans, a trade group, agreed that “patients should have access to the lowest price possible at the pharmacy.” But he said Medicare’s warning, contained in a letter in May 2018, takes aim at an increasingly rare occurrence. Gag order clauses are “not something they are incorporating into their contracts,” he said.
UnitedHealthcare, whose popular prescription drug plans dominate the market, does not include them in any of its Medicare, Medicaid, or commercial insurance contracts, said Matt Burns, a company spokesman.
Pharmacy benefit managers also said gag orders are not typical. “If it is happening, it is very much an outlier,” said Mark Merritt, president and CEO of the Pharmaceutical Care Management Association.
However, some pharmacists disagree. Kala Shankle, policy and regulatory affairs director for the National Community Pharmacists Association, which represents 22,000 independent pharmacies, said insurers have punished pharmacists who violate gag orders by dropping them from the plan’s network.
In Ohio, one of several states that have banned gag orders in insurance contracts, including some Medicare drug plans, officials responded to complaints about the problem.
“The Department has received inquiries related to entities withholding cost-saving information from consumers, which sometimes results in an insured [patient] paying more for pharmacy benefits than the actual cost of such pharmacy benefits,” the department said in April.
Illinois and Ohio state legislators are considering bills to make such restrictions illegal, and similar legislation has been introduced in the U.S. Senate.
“If we didn’t have these gag clauses, there would not be a need for the legislation and policy changes movement that’s going on in the country,” said Garth Reynolds, executive director of the Illinois Pharmacists Association.
KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. 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.
As part of President Donald Trump’s blueprint to bring down prescription costs, Medicare officials have warned insurers that “gag orders” keeping pharmacists from alerting seniors that they could save money by paying cash – rather than using their insurance – are “unacceptable and contrary” to the government’s effort to promote price transparency.
But the agency stopped short of requiring insurers to lift such restrictions on pharmacists.
That doesn’t mean people with Medicare drug coverage are destined to overpay for prescriptions. But first, they must ask the pharmacist about that option, said Julie Carter, federal policy associate at the Medicare Rights Center, a patient advocacy group.
“If they bring it up, then we can inform them of those prices,” said Nick Newman, PharmD, a pharmacist and the manager at Essentra Pharmacy in rural Marengo, Ohio. “It’s a moral dilemma for the pharmacist, knowing what would be best for the patient, but not being able to help them and hoping they will ask you about the comparison.”
A simple question could unlock some savings for millions of beneficiaries.
But details may be hard to find: Medicare’s website and annual handbook don’t mention it.
“If you don’t know that there are a bunch of different prices that could be available at any given pharmacy, you don’t know what you don’t know,” said Leigh Purvis, the AARP Public Policy Institute’s director of health services research.
Researchers analyzing 9.5 million Part D prescription claims reported in a letter in the Journal of the American Medical Association in March that a patient’s copayment was higher than the cash price for nearly one in four drugs purchased in 2013. For 12 of the 20 most commonly prescribed drugs, patients overpaid by more than 33%.
Although the study found that the average overpayment for a single prescription was relatively small, Dr. Newman said he had seen consumers pay as much as $30 more than the cash price.
And many beneficiaries may not know that, if they pay a lower cash price for a covered drug at a pharmacy that participates in their insurance plan and then submit the proper documentation, insurers must count it toward their out-of-pocket expenses. The total of those expenses can trigger the drug coverage gap, commonly called the doughnut hole. (This year, the gap begins after the plan and beneficiary spend $3,750 and ends once the beneficiary has spent a total of $5,000.)
Daniel Nam, executive director of federal programs at America’s Health Insurance Plans, a trade group, agreed that “patients should have access to the lowest price possible at the pharmacy.” But he said Medicare’s warning, contained in a letter in May 2018, takes aim at an increasingly rare occurrence. Gag order clauses are “not something they are incorporating into their contracts,” he said.
UnitedHealthcare, whose popular prescription drug plans dominate the market, does not include them in any of its Medicare, Medicaid, or commercial insurance contracts, said Matt Burns, a company spokesman.
Pharmacy benefit managers also said gag orders are not typical. “If it is happening, it is very much an outlier,” said Mark Merritt, president and CEO of the Pharmaceutical Care Management Association.
However, some pharmacists disagree. Kala Shankle, policy and regulatory affairs director for the National Community Pharmacists Association, which represents 22,000 independent pharmacies, said insurers have punished pharmacists who violate gag orders by dropping them from the plan’s network.
In Ohio, one of several states that have banned gag orders in insurance contracts, including some Medicare drug plans, officials responded to complaints about the problem.
“The Department has received inquiries related to entities withholding cost-saving information from consumers, which sometimes results in an insured [patient] paying more for pharmacy benefits than the actual cost of such pharmacy benefits,” the department said in April.
Illinois and Ohio state legislators are considering bills to make such restrictions illegal, and similar legislation has been introduced in the U.S. Senate.
“If we didn’t have these gag clauses, there would not be a need for the legislation and policy changes movement that’s going on in the country,” said Garth Reynolds, executive director of the Illinois Pharmacists Association.
KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. 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.