Women with epithelial ovarian cancer or BRCA1 mutational status were more likely to present with a community type O cervicovaginal microbiota relative to age-matched controls, according to a case-control analysis.

The results suggest that the composition of the cervicovaginal microbiome may have a key role in ovarian carcinogenesis. In addition, dysbiosis could be an important risk factor in women at high risk for the disease.

“Our aim was to establish whether women with, or at risk of developing, ovarian cancer have an imbalanced cervicovaginal microbiome,” wrote Nuno R Nené, PhD, of University College London, and colleagues. Their report is in The Lancet Oncology.

The researchers conducted a case-control study of adult females located in five European countries. Study participants were divided into two sets that consisted of 176 females with ovarian cancer and 109 females with a BRCA1 mutation, but without a diagnosis of ovarian cancer.

The two sets were matched with a combination of healthy controls and others with benign gynecologic disorders. Each cohort was split into females younger than 50 years and those over age 50.

In the analysis, females younger than 50 years with ovarian cancer were more likely to have a community type O microbiota relative to age-matched controls (adjusted odds ratio, 2.80; P = .020).

In the BRCA set, women with a BRCA1 mutation who were younger than 50 years were also more likely to present with a community type O microbiota than were wild type age-matched controls (adjusted odds ratio, 2.79; P = .012).

“In both sets, we noted that the younger the participants, the stronger the association between community type O microbiota and ovarian cancer or BRCA1 mutation status,” the researchers wrote.

They acknowledged that a key limitation of the study was the homogenous patient population. Since the vaginal microbiome can vary based on ethnicity, the generalizability of the results may be limited.

“Our findings warrant further detailed analyses of the vaginal microbiome, especially in high-risk women,” they concluded.

The study was funded by the EU’s Horizon 2020 Research and Innovation Programme, the EU’s Horizon 2020 European Research Council Programme, and The Eve Appeal. The authors reported financial affiliations with Eurofins, AstraZeneca, Biocad, Clovis, Pharmamar, Roche, Takeda, and Tesaro.

SOURCE: Nené NR et al. Lancet Oncol. 2019 Jul 9. doi: 10.1016/S1470-2045(19)30340-7.

Women with epithelial ovarian cancer or BRCA1 mutational status were more likely to present with a community type O cervicovaginal microbiota relative to age-matched controls, according to a case-control analysis.

The results suggest that the composition of the cervicovaginal microbiome may have a key role in ovarian carcinogenesis. In addition, dysbiosis could be an important risk factor in women at high risk for the disease.

“Our aim was to establish whether women with, or at risk of developing, ovarian cancer have an imbalanced cervicovaginal microbiome,” wrote Nuno R Nené, PhD, of University College London, and colleagues. Their report is in The Lancet Oncology.

The researchers conducted a case-control study of adult females located in five European countries. Study participants were divided into two sets that consisted of 176 females with ovarian cancer and 109 females with a BRCA1 mutation, but without a diagnosis of ovarian cancer.

The two sets were matched with a combination of healthy controls and others with benign gynecologic disorders. Each cohort was split into females younger than 50 years and those over age 50.

In the analysis, females younger than 50 years with ovarian cancer were more likely to have a community type O microbiota relative to age-matched controls (adjusted odds ratio, 2.80; P = .020).

In the BRCA set, women with a BRCA1 mutation who were younger than 50 years were also more likely to present with a community type O microbiota than were wild type age-matched controls (adjusted odds ratio, 2.79; P = .012).

“In both sets, we noted that the younger the participants, the stronger the association between community type O microbiota and ovarian cancer or BRCA1 mutation status,” the researchers wrote.

They acknowledged that a key limitation of the study was the homogenous patient population. Since the vaginal microbiome can vary based on ethnicity, the generalizability of the results may be limited.

“Our findings warrant further detailed analyses of the vaginal microbiome, especially in high-risk women,” they concluded.

The study was funded by the EU’s Horizon 2020 Research and Innovation Programme, the EU’s Horizon 2020 European Research Council Programme, and The Eve Appeal. The authors reported financial affiliations with Eurofins, AstraZeneca, Biocad, Clovis, Pharmamar, Roche, Takeda, and Tesaro.

SOURCE: Nené NR et al. Lancet Oncol. 2019 Jul 9. doi: 10.1016/S1470-2045(19)30340-7.

Women with epithelial ovarian cancer or BRCA1 mutational status were more likely to present with a community type O cervicovaginal microbiota relative to age-matched controls, according to a case-control analysis.

The results suggest that the composition of the cervicovaginal microbiome may have a key role in ovarian carcinogenesis. In addition, dysbiosis could be an important risk factor in women at high risk for the disease.

“Our aim was to establish whether women with, or at risk of developing, ovarian cancer have an imbalanced cervicovaginal microbiome,” wrote Nuno R Nené, PhD, of University College London, and colleagues. Their report is in The Lancet Oncology.

The researchers conducted a case-control study of adult females located in five European countries. Study participants were divided into two sets that consisted of 176 females with ovarian cancer and 109 females with a BRCA1 mutation, but without a diagnosis of ovarian cancer.

The two sets were matched with a combination of healthy controls and others with benign gynecologic disorders. Each cohort was split into females younger than 50 years and those over age 50.

In the analysis, females younger than 50 years with ovarian cancer were more likely to have a community type O microbiota relative to age-matched controls (adjusted odds ratio, 2.80; P = .020).

In the BRCA set, women with a BRCA1 mutation who were younger than 50 years were also more likely to present with a community type O microbiota than were wild type age-matched controls (adjusted odds ratio, 2.79; P = .012).

“In both sets, we noted that the younger the participants, the stronger the association between community type O microbiota and ovarian cancer or BRCA1 mutation status,” the researchers wrote.

They acknowledged that a key limitation of the study was the homogenous patient population. Since the vaginal microbiome can vary based on ethnicity, the generalizability of the results may be limited.

“Our findings warrant further detailed analyses of the vaginal microbiome, especially in high-risk women,” they concluded.

The study was funded by the EU’s Horizon 2020 Research and Innovation Programme, the EU’s Horizon 2020 European Research Council Programme, and The Eve Appeal. The authors reported financial affiliations with Eurofins, AstraZeneca, Biocad, Clovis, Pharmamar, Roche, Takeda, and Tesaro.

SOURCE: Nené NR et al. Lancet Oncol. 2019 Jul 9. doi: 10.1016/S1470-2045(19)30340-7.

Health insurers that cover millions of seniors have overcharged Medicare by nearly $30 billion the past 3 years alone, but federal officials say they are moving ahead with long-delayed plans to recoup at least part of the money.

Officials have known for years that some Medicare Advantage plans overbill the government by exaggerating how sick their members are or by charging Medicare for treatment of serious medical conditions they cannot prove their members have.

Getting refunds from the health plans has proved daunting, however. Officials with the Centers for Medicare & Medicaid Services repeatedly have postponed, or backed off, efforts to crack down on billing abuses and mistakes by the increasingly popular Medicare Advantage health plans offered by private health insurers under contract with Medicare. Today, such plans treat over 22 million seniors, more than 1 in 3 people on Medicare.

Now CMS is trying again, proposing a series of enhanced audits tailored to claw back $1 billion in Medicare Advantage overpayments by 2020 – just a tenth of what it estimates the plans overcharge the government in a given year.

At the same time, the Department of Health and Human Services Inspector General’s Office has launched a separate nationwide round of Medicare Advantage audits.

As in past years, such scrutiny faces an onslaught of criticism from the insurance industry, which argues the CMS audits especially are technically unsound and unfair and could jeopardize medical services for seniors.

America’s Health Insurance Plans, an industry trade group, blasted the CMS audit design when details emerged last fall, calling it “fatally flawed.”

Insurer Cigna Corp. warned in a May financial filing: “If adopted in its current form, [the audits] could have a detrimental impact” on all Medicare Advantage plans and “affect the ability of plans to deliver high quality care.”

But former Sen. Claire McCaskill, a Missouri Democrat who now works as a political analyst, said officials must move past powerful lobbying efforts to hold health insurers accountable and demand refunds for “inappropriate” billings.

“There’s a lot of things that could cause Medicare to go broke. This would be one of the contributing factors,” she said. “Ten billion dollars a year is real money.”
 

Catching overbilling with a wider net

In the overpayment dispute, health plans want CMS to scale back – if not kill off – an enhanced audit tool that, for the first time, could force insurers to cough up millions in improper payments they’ve received.

For over a decade, audits have been little more than an irritant to insurers because most plans go years without being chosen for review and often pay only a few hundred thousand dollars in refunds as a consequence. When auditors uncover errors in the medical records of patients they paid the companies to treat, CMS has simply required a rebate for those patients for just the year audited – relatively small sums for plans with thousands of members.

The latest CMS proposal would raise those stakes enormously by extrapolating error rates found in a random sample of 200 patients to the plan’s full membership – a technique expected to trigger many multimillion-dollar penalties. Though controversial, extrapolation is common in medical fraud investigations – except for investigations into Medicare Advantage. Since 2007, the industry has successfully challenged the extrapolation method and, as a result, largely avoided accountability for pervasive billing errors.

“The public has a substantial interest in the recoupment of millions of dollars of public money improperly paid to health insurers,” CMS wrote in a Federal Register notice late last year announcing its renewed attempt at using extrapolation.
 

Penalties in limbo

In a written response to questions posed by Kaiser Health News, CMS officials said the agency has already conducted 90 of those enhanced audits for payments made in 2011, 2012 and 2013 – and expects to collect $650 million in extrapolated penalties as a result.

Though that figure reflects only a minute percentage of actual losses to taxpayers from overpayments, it would be a huge escalation for CMS. Previous Medicare Advantage audits have recouped a total of about $14 million, far less than it cost to conduct them, federal records show.

Though CMS has disclosed the names of the health plans in the crossfire, it has not yet told them how much each owes, officials said. CMS declined to say when, or if, they would make the results public.

This year, CMS is starting audits for 2014 and 2015, 30 per year, targeting about 5% of the 600 plans annually.

This spring, CMS announced it would extend until the end of August the audit proposal’s public comment period, which was supposed to end in April. That could be a signal the agency might be looking more closely at industry objections.

Health care industry consultant Jessica Smith said CMS might be taking additional time to make sure the audit protocol can pass muster. “Once they have their ducks in a row, CMS will come back hard at the health plans. There is so much money tied to this.”

But Sean Creighton, a former senior CMS official who now advises the industry for health care consultant Avalere Health, said payment error rates have been dropping because many health plans “are trying as hard as they can to become compliant.”

Still, audits are continuing to find mistakes. The first HHS inspector general audit, released in late April, found that Missouri-based Essence Healthcare Inc. had failed to justify fees for dozens of patients it had covered for strokes or depression. Essence denied any wrongdoing but agreed it should refund $158,904 in overcharges for those patients and ferret out any other errors.

Essence also faces a pending whistle-blower suit filed by Charles Rasmussen, a Branson, Mo., doctor who alleges the health plan illegally boosted profits by overstating the severity of patients’ medical conditions. Essence has called the allegations “wholly without merit” and “baseless.”

Essence started as a St. Louis physician group, then grew into a broader holding company backed by prominent Silicon Valley venture capitalist John Doerr with his brother, St. Louis doctor and software designer Thomas Doerr, in 2007. Neither would comment on the allegations.
 

How we got here

CMS uses a billing formula called a “risk score” to pay for each Medicare Advantage member. The formula pays higher rates for sicker patients than for people in good health.

Congress approved risk scoring in 2003 to ensure health plans did not shy away from taking sick patients who could incur higher-than-usual costs from hospitals and other medical facilities. But some insurers quickly found ways to boost risk scores – and their revenues.

In 2007, after several years of running Medicare Advantage as what one CMS official dubbed an “honor system,” the agency launched “Risk Adjustment Data Validation,” or RADV, audits. The idea was to cut down on undeserved payments that cost CMS nearly $30 billion over the past 3 years.

The audits of 37 health plans revealed that on average auditors could confirm just 60% of the more than 20,000 medical conditions CMS had paid the plans to treat.

Extra payments to plans that had claimed some of its diabetic patients had complications, such as eye or kidney problems, were reduced or invalidated in nearly half the cases. The overpayments exceeded $10,000 a year for more than 150 patients, though health plans disputed some of the findings.

But CMS kept the findings under wraps until the Center for Public Integrity sued the agency under the Freedom of Information Act to make them public.

Despite the alarming results, CMS conducted no audits for payments made during 2008, 2009 and 2010 as they faced industry backlash over CMS’ authority to conduct them, and the threat of extrapolated repayments. Some inside the agency also worried that health plans would abandon the Medicare Advantage program if CMS pressed them too hard, records released through the FOIA lawsuit show.

CMS officials resumed the audits for 2011 and expected to finish them and assess penalties by the end of 2016. That has yet to happen amid the continuing protests from the industry. Insurers want CMS to adjust downward any extrapolated penalties to account for coding errors that exist in standard Medicare. CMS stands behind its method – at least for now.

At a minimum, argues AHIP, the health insurers association, CMS should back off extrapolation for the 90 audits for 2011-13 and apply it for 2014 and onward. Should CMS agree, it would write off more than half a billion dollars that could be recovered for the U.S. Treasury.
 

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.

Health insurers that cover millions of seniors have overcharged Medicare by nearly $30 billion the past 3 years alone, but federal officials say they are moving ahead with long-delayed plans to recoup at least part of the money.

Officials have known for years that some Medicare Advantage plans overbill the government by exaggerating how sick their members are or by charging Medicare for treatment of serious medical conditions they cannot prove their members have.

Getting refunds from the health plans has proved daunting, however. Officials with the Centers for Medicare & Medicaid Services repeatedly have postponed, or backed off, efforts to crack down on billing abuses and mistakes by the increasingly popular Medicare Advantage health plans offered by private health insurers under contract with Medicare. Today, such plans treat over 22 million seniors, more than 1 in 3 people on Medicare.

Now CMS is trying again, proposing a series of enhanced audits tailored to claw back $1 billion in Medicare Advantage overpayments by 2020 – just a tenth of what it estimates the plans overcharge the government in a given year.

At the same time, the Department of Health and Human Services Inspector General’s Office has launched a separate nationwide round of Medicare Advantage audits.

As in past years, such scrutiny faces an onslaught of criticism from the insurance industry, which argues the CMS audits especially are technically unsound and unfair and could jeopardize medical services for seniors.

America’s Health Insurance Plans, an industry trade group, blasted the CMS audit design when details emerged last fall, calling it “fatally flawed.”

Insurer Cigna Corp. warned in a May financial filing: “If adopted in its current form, [the audits] could have a detrimental impact” on all Medicare Advantage plans and “affect the ability of plans to deliver high quality care.”

But former Sen. Claire McCaskill, a Missouri Democrat who now works as a political analyst, said officials must move past powerful lobbying efforts to hold health insurers accountable and demand refunds for “inappropriate” billings.

“There’s a lot of things that could cause Medicare to go broke. This would be one of the contributing factors,” she said. “Ten billion dollars a year is real money.”
 

Catching overbilling with a wider net

In the overpayment dispute, health plans want CMS to scale back – if not kill off – an enhanced audit tool that, for the first time, could force insurers to cough up millions in improper payments they’ve received.

For over a decade, audits have been little more than an irritant to insurers because most plans go years without being chosen for review and often pay only a few hundred thousand dollars in refunds as a consequence. When auditors uncover errors in the medical records of patients they paid the companies to treat, CMS has simply required a rebate for those patients for just the year audited – relatively small sums for plans with thousands of members.

The latest CMS proposal would raise those stakes enormously by extrapolating error rates found in a random sample of 200 patients to the plan’s full membership – a technique expected to trigger many multimillion-dollar penalties. Though controversial, extrapolation is common in medical fraud investigations – except for investigations into Medicare Advantage. Since 2007, the industry has successfully challenged the extrapolation method and, as a result, largely avoided accountability for pervasive billing errors.

“The public has a substantial interest in the recoupment of millions of dollars of public money improperly paid to health insurers,” CMS wrote in a Federal Register notice late last year announcing its renewed attempt at using extrapolation.
 

Penalties in limbo

In a written response to questions posed by Kaiser Health News, CMS officials said the agency has already conducted 90 of those enhanced audits for payments made in 2011, 2012 and 2013 – and expects to collect $650 million in extrapolated penalties as a result.

Though that figure reflects only a minute percentage of actual losses to taxpayers from overpayments, it would be a huge escalation for CMS. Previous Medicare Advantage audits have recouped a total of about $14 million, far less than it cost to conduct them, federal records show.

Though CMS has disclosed the names of the health plans in the crossfire, it has not yet told them how much each owes, officials said. CMS declined to say when, or if, they would make the results public.

This year, CMS is starting audits for 2014 and 2015, 30 per year, targeting about 5% of the 600 plans annually.

This spring, CMS announced it would extend until the end of August the audit proposal’s public comment period, which was supposed to end in April. That could be a signal the agency might be looking more closely at industry objections.

Health care industry consultant Jessica Smith said CMS might be taking additional time to make sure the audit protocol can pass muster. “Once they have their ducks in a row, CMS will come back hard at the health plans. There is so much money tied to this.”

But Sean Creighton, a former senior CMS official who now advises the industry for health care consultant Avalere Health, said payment error rates have been dropping because many health plans “are trying as hard as they can to become compliant.”

Still, audits are continuing to find mistakes. The first HHS inspector general audit, released in late April, found that Missouri-based Essence Healthcare Inc. had failed to justify fees for dozens of patients it had covered for strokes or depression. Essence denied any wrongdoing but agreed it should refund $158,904 in overcharges for those patients and ferret out any other errors.

Essence also faces a pending whistle-blower suit filed by Charles Rasmussen, a Branson, Mo., doctor who alleges the health plan illegally boosted profits by overstating the severity of patients’ medical conditions. Essence has called the allegations “wholly without merit” and “baseless.”

Essence started as a St. Louis physician group, then grew into a broader holding company backed by prominent Silicon Valley venture capitalist John Doerr with his brother, St. Louis doctor and software designer Thomas Doerr, in 2007. Neither would comment on the allegations.
 

How we got here

CMS uses a billing formula called a “risk score” to pay for each Medicare Advantage member. The formula pays higher rates for sicker patients than for people in good health.

Congress approved risk scoring in 2003 to ensure health plans did not shy away from taking sick patients who could incur higher-than-usual costs from hospitals and other medical facilities. But some insurers quickly found ways to boost risk scores – and their revenues.

In 2007, after several years of running Medicare Advantage as what one CMS official dubbed an “honor system,” the agency launched “Risk Adjustment Data Validation,” or RADV, audits. The idea was to cut down on undeserved payments that cost CMS nearly $30 billion over the past 3 years.

The audits of 37 health plans revealed that on average auditors could confirm just 60% of the more than 20,000 medical conditions CMS had paid the plans to treat.

Extra payments to plans that had claimed some of its diabetic patients had complications, such as eye or kidney problems, were reduced or invalidated in nearly half the cases. The overpayments exceeded $10,000 a year for more than 150 patients, though health plans disputed some of the findings.

But CMS kept the findings under wraps until the Center for Public Integrity sued the agency under the Freedom of Information Act to make them public.

Despite the alarming results, CMS conducted no audits for payments made during 2008, 2009 and 2010 as they faced industry backlash over CMS’ authority to conduct them, and the threat of extrapolated repayments. Some inside the agency also worried that health plans would abandon the Medicare Advantage program if CMS pressed them too hard, records released through the FOIA lawsuit show.

CMS officials resumed the audits for 2011 and expected to finish them and assess penalties by the end of 2016. That has yet to happen amid the continuing protests from the industry. Insurers want CMS to adjust downward any extrapolated penalties to account for coding errors that exist in standard Medicare. CMS stands behind its method – at least for now.

At a minimum, argues AHIP, the health insurers association, CMS should back off extrapolation for the 90 audits for 2011-13 and apply it for 2014 and onward. Should CMS agree, it would write off more than half a billion dollars that could be recovered for the U.S. Treasury.
 

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.

Health insurers that cover millions of seniors have overcharged Medicare by nearly $30 billion the past 3 years alone, but federal officials say they are moving ahead with long-delayed plans to recoup at least part of the money.

Officials have known for years that some Medicare Advantage plans overbill the government by exaggerating how sick their members are or by charging Medicare for treatment of serious medical conditions they cannot prove their members have.

Getting refunds from the health plans has proved daunting, however. Officials with the Centers for Medicare & Medicaid Services repeatedly have postponed, or backed off, efforts to crack down on billing abuses and mistakes by the increasingly popular Medicare Advantage health plans offered by private health insurers under contract with Medicare. Today, such plans treat over 22 million seniors, more than 1 in 3 people on Medicare.

Now CMS is trying again, proposing a series of enhanced audits tailored to claw back $1 billion in Medicare Advantage overpayments by 2020 – just a tenth of what it estimates the plans overcharge the government in a given year.

At the same time, the Department of Health and Human Services Inspector General’s Office has launched a separate nationwide round of Medicare Advantage audits.

As in past years, such scrutiny faces an onslaught of criticism from the insurance industry, which argues the CMS audits especially are technically unsound and unfair and could jeopardize medical services for seniors.

America’s Health Insurance Plans, an industry trade group, blasted the CMS audit design when details emerged last fall, calling it “fatally flawed.”

Insurer Cigna Corp. warned in a May financial filing: “If adopted in its current form, [the audits] could have a detrimental impact” on all Medicare Advantage plans and “affect the ability of plans to deliver high quality care.”

But former Sen. Claire McCaskill, a Missouri Democrat who now works as a political analyst, said officials must move past powerful lobbying efforts to hold health insurers accountable and demand refunds for “inappropriate” billings.

“There’s a lot of things that could cause Medicare to go broke. This would be one of the contributing factors,” she said. “Ten billion dollars a year is real money.”
 

Catching overbilling with a wider net

In the overpayment dispute, health plans want CMS to scale back – if not kill off – an enhanced audit tool that, for the first time, could force insurers to cough up millions in improper payments they’ve received.

For over a decade, audits have been little more than an irritant to insurers because most plans go years without being chosen for review and often pay only a few hundred thousand dollars in refunds as a consequence. When auditors uncover errors in the medical records of patients they paid the companies to treat, CMS has simply required a rebate for those patients for just the year audited – relatively small sums for plans with thousands of members.

The latest CMS proposal would raise those stakes enormously by extrapolating error rates found in a random sample of 200 patients to the plan’s full membership – a technique expected to trigger many multimillion-dollar penalties. Though controversial, extrapolation is common in medical fraud investigations – except for investigations into Medicare Advantage. Since 2007, the industry has successfully challenged the extrapolation method and, as a result, largely avoided accountability for pervasive billing errors.

“The public has a substantial interest in the recoupment of millions of dollars of public money improperly paid to health insurers,” CMS wrote in a Federal Register notice late last year announcing its renewed attempt at using extrapolation.
 

Penalties in limbo

In a written response to questions posed by Kaiser Health News, CMS officials said the agency has already conducted 90 of those enhanced audits for payments made in 2011, 2012 and 2013 – and expects to collect $650 million in extrapolated penalties as a result.

Though that figure reflects only a minute percentage of actual losses to taxpayers from overpayments, it would be a huge escalation for CMS. Previous Medicare Advantage audits have recouped a total of about $14 million, far less than it cost to conduct them, federal records show.

Though CMS has disclosed the names of the health plans in the crossfire, it has not yet told them how much each owes, officials said. CMS declined to say when, or if, they would make the results public.

This year, CMS is starting audits for 2014 and 2015, 30 per year, targeting about 5% of the 600 plans annually.

This spring, CMS announced it would extend until the end of August the audit proposal’s public comment period, which was supposed to end in April. That could be a signal the agency might be looking more closely at industry objections.

Health care industry consultant Jessica Smith said CMS might be taking additional time to make sure the audit protocol can pass muster. “Once they have their ducks in a row, CMS will come back hard at the health plans. There is so much money tied to this.”

But Sean Creighton, a former senior CMS official who now advises the industry for health care consultant Avalere Health, said payment error rates have been dropping because many health plans “are trying as hard as they can to become compliant.”

Still, audits are continuing to find mistakes. The first HHS inspector general audit, released in late April, found that Missouri-based Essence Healthcare Inc. had failed to justify fees for dozens of patients it had covered for strokes or depression. Essence denied any wrongdoing but agreed it should refund $158,904 in overcharges for those patients and ferret out any other errors.

Essence also faces a pending whistle-blower suit filed by Charles Rasmussen, a Branson, Mo., doctor who alleges the health plan illegally boosted profits by overstating the severity of patients’ medical conditions. Essence has called the allegations “wholly without merit” and “baseless.”

Essence started as a St. Louis physician group, then grew into a broader holding company backed by prominent Silicon Valley venture capitalist John Doerr with his brother, St. Louis doctor and software designer Thomas Doerr, in 2007. Neither would comment on the allegations.
 

How we got here

CMS uses a billing formula called a “risk score” to pay for each Medicare Advantage member. The formula pays higher rates for sicker patients than for people in good health.

Congress approved risk scoring in 2003 to ensure health plans did not shy away from taking sick patients who could incur higher-than-usual costs from hospitals and other medical facilities. But some insurers quickly found ways to boost risk scores – and their revenues.

In 2007, after several years of running Medicare Advantage as what one CMS official dubbed an “honor system,” the agency launched “Risk Adjustment Data Validation,” or RADV, audits. The idea was to cut down on undeserved payments that cost CMS nearly $30 billion over the past 3 years.

The audits of 37 health plans revealed that on average auditors could confirm just 60% of the more than 20,000 medical conditions CMS had paid the plans to treat.

Extra payments to plans that had claimed some of its diabetic patients had complications, such as eye or kidney problems, were reduced or invalidated in nearly half the cases. The overpayments exceeded $10,000 a year for more than 150 patients, though health plans disputed some of the findings.

But CMS kept the findings under wraps until the Center for Public Integrity sued the agency under the Freedom of Information Act to make them public.

Despite the alarming results, CMS conducted no audits for payments made during 2008, 2009 and 2010 as they faced industry backlash over CMS’ authority to conduct them, and the threat of extrapolated repayments. Some inside the agency also worried that health plans would abandon the Medicare Advantage program if CMS pressed them too hard, records released through the FOIA lawsuit show.

CMS officials resumed the audits for 2011 and expected to finish them and assess penalties by the end of 2016. That has yet to happen amid the continuing protests from the industry. Insurers want CMS to adjust downward any extrapolated penalties to account for coding errors that exist in standard Medicare. CMS stands behind its method – at least for now.

At a minimum, argues AHIP, the health insurers association, CMS should back off extrapolation for the 90 audits for 2011-13 and apply it for 2014 and onward. Should CMS agree, it would write off more than half a billion dollars that could be recovered for the U.S. Treasury.
 

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.

Progressive macular hypomelanosis (PMH) presents as asymptomatic, ill-defined hypopigmented macules and patches on the trunk and back. They often coalesce near the midline, and occasionally extend beyond the trunk to the arms, legs, head, or neck. PMH is more frequently diagnosed among black individuals, although it affects all races and ethnicities. The natural history of PMH can vary from stable and progressive disease, and may resolve spontaneously after a few years. The pathogenesis of PMH remains unknown. It has been proposed that the hypopigmentation is caused by decreased melanin production and altered melanosome dispersal in reaction to Propionibacterium acnes.

PMH must be distinguished from some of its clinical mimickers, including vitiligo, hypopigmented mycosis fungoides, tinea versicolor, and pityriasis alba. Potassium hydroxide preparations can be performed in the office to evaluate for tinea versicolor. An additional tool to aid in diagnosis is the use of a Wood’s light. The lesions of PMH characteristically show punctiform orange-red follicular fluorescence when exposed to a Wood’s light, indicating the presence of a porphyrin-producing organism, presumably P. acnes. A skin biopsy is necessary to rule out hypopigmented mycosis fungoides.

Skin biopsy of PMH typically reveals decreased melanin with a normal number of melanocytes. In our patient, a punch biopsy of the right lateral arm demonstrated minimally decreased density of epidermal melanocytes with dermal pigment incontinence. SOX10 immunohistochemical staining demonstrated scattered melanocytes in the epidermis. Preserved melanin within keratinocytes was noted.

In our patient, there was significant spread to the face, which is highly unusual and has only been documented in a few case series. There are no standard recommendations for definitive treatment of PMH. Topical antimicrobial therapies, such as clindamycin solution and benzoyl peroxide gel, have been beneficial in some studies. Tetracyclines, narrow-band ultraviolet B phototherapy, and even isotretinoin have had some reported success.

This case and photo were submitted by Mr. Franzetti, Dr. Rush, and Dr. Shalin of the University of Arkansas for Medical Sciences, Little Rock.

Donna Bilu Martin, MD, is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to dermnews@mdedge.com.

Progressive macular hypomelanosis (PMH) presents as asymptomatic, ill-defined hypopigmented macules and patches on the trunk and back. They often coalesce near the midline, and occasionally extend beyond the trunk to the arms, legs, head, or neck. PMH is more frequently diagnosed among black individuals, although it affects all races and ethnicities. The natural history of PMH can vary from stable and progressive disease, and may resolve spontaneously after a few years. The pathogenesis of PMH remains unknown. It has been proposed that the hypopigmentation is caused by decreased melanin production and altered melanosome dispersal in reaction to Propionibacterium acnes.

PMH must be distinguished from some of its clinical mimickers, including vitiligo, hypopigmented mycosis fungoides, tinea versicolor, and pityriasis alba. Potassium hydroxide preparations can be performed in the office to evaluate for tinea versicolor. An additional tool to aid in diagnosis is the use of a Wood’s light. The lesions of PMH characteristically show punctiform orange-red follicular fluorescence when exposed to a Wood’s light, indicating the presence of a porphyrin-producing organism, presumably P. acnes. A skin biopsy is necessary to rule out hypopigmented mycosis fungoides.

Skin biopsy of PMH typically reveals decreased melanin with a normal number of melanocytes. In our patient, a punch biopsy of the right lateral arm demonstrated minimally decreased density of epidermal melanocytes with dermal pigment incontinence. SOX10 immunohistochemical staining demonstrated scattered melanocytes in the epidermis. Preserved melanin within keratinocytes was noted.

In our patient, there was significant spread to the face, which is highly unusual and has only been documented in a few case series. There are no standard recommendations for definitive treatment of PMH. Topical antimicrobial therapies, such as clindamycin solution and benzoyl peroxide gel, have been beneficial in some studies. Tetracyclines, narrow-band ultraviolet B phototherapy, and even isotretinoin have had some reported success.

This case and photo were submitted by Mr. Franzetti, Dr. Rush, and Dr. Shalin of the University of Arkansas for Medical Sciences, Little Rock.

Donna Bilu Martin, MD, is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to dermnews@mdedge.com.

Progressive macular hypomelanosis (PMH) presents as asymptomatic, ill-defined hypopigmented macules and patches on the trunk and back. They often coalesce near the midline, and occasionally extend beyond the trunk to the arms, legs, head, or neck. PMH is more frequently diagnosed among black individuals, although it affects all races and ethnicities. The natural history of PMH can vary from stable and progressive disease, and may resolve spontaneously after a few years. The pathogenesis of PMH remains unknown. It has been proposed that the hypopigmentation is caused by decreased melanin production and altered melanosome dispersal in reaction to Propionibacterium acnes.

PMH must be distinguished from some of its clinical mimickers, including vitiligo, hypopigmented mycosis fungoides, tinea versicolor, and pityriasis alba. Potassium hydroxide preparations can be performed in the office to evaluate for tinea versicolor. An additional tool to aid in diagnosis is the use of a Wood’s light. The lesions of PMH characteristically show punctiform orange-red follicular fluorescence when exposed to a Wood’s light, indicating the presence of a porphyrin-producing organism, presumably P. acnes. A skin biopsy is necessary to rule out hypopigmented mycosis fungoides.

Skin biopsy of PMH typically reveals decreased melanin with a normal number of melanocytes. In our patient, a punch biopsy of the right lateral arm demonstrated minimally decreased density of epidermal melanocytes with dermal pigment incontinence. SOX10 immunohistochemical staining demonstrated scattered melanocytes in the epidermis. Preserved melanin within keratinocytes was noted.

In our patient, there was significant spread to the face, which is highly unusual and has only been documented in a few case series. There are no standard recommendations for definitive treatment of PMH. Topical antimicrobial therapies, such as clindamycin solution and benzoyl peroxide gel, have been beneficial in some studies. Tetracyclines, narrow-band ultraviolet B phototherapy, and even isotretinoin have had some reported success.

This case and photo were submitted by Mr. Franzetti, Dr. Rush, and Dr. Shalin of the University of Arkansas for Medical Sciences, Little Rock.

Donna Bilu Martin, MD, is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to dermnews@mdedge.com.

Intuitively, we have come to believe that adding more to each family members’ schedule – a lesson, an activity, more homework time – is more enriching or meaningful than is a family dinner, which appears to have less direct impact. However, there is a growing body of evidence that, when an entire family eats dinner together 5 or more nights weekly, the emotional health and well-being of all family members is improved. Not only is their health improved, as there is a greater likelihood of eating nutritious food, but so are a child’s school performance and emotional well-being. As the frequency of eating dinner with parents goes up, the rates of mood and anxiety disorders and high-risk behaviors in teenagers go down.

Wavebreakmedia/Thinkstock

But less than 60% of children eat five or more meals with their parents each week (National Center on Addiction and Substance Abuse [CASA], 2012). Few people would suggest that encouraging families to eat dinner together is a bad idea, but time is the ultimate scarce resource. Preparing food and eating together takes time, and parents and children have many demands on that time that feel nonnegotiable, such as homework, exercise, team practice, or work obligations. When you meet with your patients and explain the tremendous health benefits of eating dinner together, you help your patients and their parents make informed decisions about how to rebalance time to prioritize family dinners that have real but fewer obvious impacts then do a piano lesson or dance class.

Of course, children who eat regular family dinners eat more fruits and vegetables and fewer fried foods and soft drinks than do their peers who eat dinner with their families less often. They are less likely to become obese in youth and more likely to eat healthily and maintain a healthy weight once they live on their own as adults.

It is important to set the framework for what really matters in a family dinner so that your patients can enjoy all of these benefits. Parents may assume that the meal must be prepared from scratch with only fresh, local, or organic ingredients. But what matters most is that the food is delicious and nutritious, and that the time spent eating (and preparing it) is fun, and promotes conversation and connection. Homemade food usually is more nutritious and will bring more of the physical health benefits, but many store-bought ingredients or even take-out options can be healthy and can promote time for the family to sit together and connect. If parents enjoy preparing food, then it’s worthwhile! And they should not worry about having every member of the family together at every meal. Even if only one parent and child are present for a dinner, they each will enjoy the benefits.

Offer some ideas about how to facilitate conversations. Asking about how a child’s day went may spark conversations sometimes, but usually people benefit from specific questions. What made you really laugh today? What did you have for lunch? Whom did you sit next to on the bus? If a parent starts by telling a story about his or her day, even better! This is especially potent if a parent talks about something embarrassing or challenging, or mentions a failure. Young children will have plenty of these stories, and adolescents build resilience by internalizing the idea that setbacks and difficulties are a normal, healthy part of every day. This is a great time to talk about current events, whether in the news, entertainment, or sports. And telling stories about when children were younger, when the parents were children, or even about grandparents or more distant ancestors is a wonderful way to engage children in the greater story of their family narrative, and is always engaging and memorable.

At a deeper level, the family dinner is a time that recognizes each person’s contribution to a discussion, and facilitates a calm discussion of the families’ history and values. There is connection, communication, and building of trust. Families that cannot schedule a minimum number of dinners or that have dinners filled with tension and conflict, are very likely to have children at risk. For those conflicted and often unhappy families, a pediatrician’s early recognition and intervention could make a meaningful difference.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com.

References

1. J Adolesc Health. 2006;39(3):337-45.

2. J Adolesc. 2010;33(1):187-96.

3. J Adolesc Health. 2009;44(5):431-6.

4. Health Psychol. 2008;27(Suppl 2):s109-17.

5. J Adolesc Health. 2009;45(4):389-95.

6. Pediatrics. 2019 Jul 8. doi: 10.1542/peds.2018-945.

7. Arch Pediatr Adolesc Med. 2004;158(8):792-6.

8. Prev Med. 2018;113:7-12.

Intuitively, we have come to believe that adding more to each family members’ schedule – a lesson, an activity, more homework time – is more enriching or meaningful than is a family dinner, which appears to have less direct impact. However, there is a growing body of evidence that, when an entire family eats dinner together 5 or more nights weekly, the emotional health and well-being of all family members is improved. Not only is their health improved, as there is a greater likelihood of eating nutritious food, but so are a child’s school performance and emotional well-being. As the frequency of eating dinner with parents goes up, the rates of mood and anxiety disorders and high-risk behaviors in teenagers go down.

Wavebreakmedia/Thinkstock

But less than 60% of children eat five or more meals with their parents each week (National Center on Addiction and Substance Abuse [CASA], 2012). Few people would suggest that encouraging families to eat dinner together is a bad idea, but time is the ultimate scarce resource. Preparing food and eating together takes time, and parents and children have many demands on that time that feel nonnegotiable, such as homework, exercise, team practice, or work obligations. When you meet with your patients and explain the tremendous health benefits of eating dinner together, you help your patients and their parents make informed decisions about how to rebalance time to prioritize family dinners that have real but fewer obvious impacts then do a piano lesson or dance class.

Of course, children who eat regular family dinners eat more fruits and vegetables and fewer fried foods and soft drinks than do their peers who eat dinner with their families less often. They are less likely to become obese in youth and more likely to eat healthily and maintain a healthy weight once they live on their own as adults.

It is important to set the framework for what really matters in a family dinner so that your patients can enjoy all of these benefits. Parents may assume that the meal must be prepared from scratch with only fresh, local, or organic ingredients. But what matters most is that the food is delicious and nutritious, and that the time spent eating (and preparing it) is fun, and promotes conversation and connection. Homemade food usually is more nutritious and will bring more of the physical health benefits, but many store-bought ingredients or even take-out options can be healthy and can promote time for the family to sit together and connect. If parents enjoy preparing food, then it’s worthwhile! And they should not worry about having every member of the family together at every meal. Even if only one parent and child are present for a dinner, they each will enjoy the benefits.

Offer some ideas about how to facilitate conversations. Asking about how a child’s day went may spark conversations sometimes, but usually people benefit from specific questions. What made you really laugh today? What did you have for lunch? Whom did you sit next to on the bus? If a parent starts by telling a story about his or her day, even better! This is especially potent if a parent talks about something embarrassing or challenging, or mentions a failure. Young children will have plenty of these stories, and adolescents build resilience by internalizing the idea that setbacks and difficulties are a normal, healthy part of every day. This is a great time to talk about current events, whether in the news, entertainment, or sports. And telling stories about when children were younger, when the parents were children, or even about grandparents or more distant ancestors is a wonderful way to engage children in the greater story of their family narrative, and is always engaging and memorable.

At a deeper level, the family dinner is a time that recognizes each person’s contribution to a discussion, and facilitates a calm discussion of the families’ history and values. There is connection, communication, and building of trust. Families that cannot schedule a minimum number of dinners or that have dinners filled with tension and conflict, are very likely to have children at risk. For those conflicted and often unhappy families, a pediatrician’s early recognition and intervention could make a meaningful difference.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com.

References

1. J Adolesc Health. 2006;39(3):337-45.

2. J Adolesc. 2010;33(1):187-96.

3. J Adolesc Health. 2009;44(5):431-6.

4. Health Psychol. 2008;27(Suppl 2):s109-17.

5. J Adolesc Health. 2009;45(4):389-95.

6. Pediatrics. 2019 Jul 8. doi: 10.1542/peds.2018-945.

7. Arch Pediatr Adolesc Med. 2004;158(8):792-6.

8. Prev Med. 2018;113:7-12.

Intuitively, we have come to believe that adding more to each family members’ schedule – a lesson, an activity, more homework time – is more enriching or meaningful than is a family dinner, which appears to have less direct impact. However, there is a growing body of evidence that, when an entire family eats dinner together 5 or more nights weekly, the emotional health and well-being of all family members is improved. Not only is their health improved, as there is a greater likelihood of eating nutritious food, but so are a child’s school performance and emotional well-being. As the frequency of eating dinner with parents goes up, the rates of mood and anxiety disorders and high-risk behaviors in teenagers go down.

Wavebreakmedia/Thinkstock

But less than 60% of children eat five or more meals with their parents each week (National Center on Addiction and Substance Abuse [CASA], 2012). Few people would suggest that encouraging families to eat dinner together is a bad idea, but time is the ultimate scarce resource. Preparing food and eating together takes time, and parents and children have many demands on that time that feel nonnegotiable, such as homework, exercise, team practice, or work obligations. When you meet with your patients and explain the tremendous health benefits of eating dinner together, you help your patients and their parents make informed decisions about how to rebalance time to prioritize family dinners that have real but fewer obvious impacts then do a piano lesson or dance class.

Of course, children who eat regular family dinners eat more fruits and vegetables and fewer fried foods and soft drinks than do their peers who eat dinner with their families less often. They are less likely to become obese in youth and more likely to eat healthily and maintain a healthy weight once they live on their own as adults.

It is important to set the framework for what really matters in a family dinner so that your patients can enjoy all of these benefits. Parents may assume that the meal must be prepared from scratch with only fresh, local, or organic ingredients. But what matters most is that the food is delicious and nutritious, and that the time spent eating (and preparing it) is fun, and promotes conversation and connection. Homemade food usually is more nutritious and will bring more of the physical health benefits, but many store-bought ingredients or even take-out options can be healthy and can promote time for the family to sit together and connect. If parents enjoy preparing food, then it’s worthwhile! And they should not worry about having every member of the family together at every meal. Even if only one parent and child are present for a dinner, they each will enjoy the benefits.

Offer some ideas about how to facilitate conversations. Asking about how a child’s day went may spark conversations sometimes, but usually people benefit from specific questions. What made you really laugh today? What did you have for lunch? Whom did you sit next to on the bus? If a parent starts by telling a story about his or her day, even better! This is especially potent if a parent talks about something embarrassing or challenging, or mentions a failure. Young children will have plenty of these stories, and adolescents build resilience by internalizing the idea that setbacks and difficulties are a normal, healthy part of every day. This is a great time to talk about current events, whether in the news, entertainment, or sports. And telling stories about when children were younger, when the parents were children, or even about grandparents or more distant ancestors is a wonderful way to engage children in the greater story of their family narrative, and is always engaging and memorable.

At a deeper level, the family dinner is a time that recognizes each person’s contribution to a discussion, and facilitates a calm discussion of the families’ history and values. There is connection, communication, and building of trust. Families that cannot schedule a minimum number of dinners or that have dinners filled with tension and conflict, are very likely to have children at risk. For those conflicted and often unhappy families, a pediatrician’s early recognition and intervention could make a meaningful difference.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com.

References

1. J Adolesc Health. 2006;39(3):337-45.

2. J Adolesc. 2010;33(1):187-96.

3. J Adolesc Health. 2009;44(5):431-6.

4. Health Psychol. 2008;27(Suppl 2):s109-17.

5. J Adolesc Health. 2009;45(4):389-95.

6. Pediatrics. 2019 Jul 8. doi: 10.1542/peds.2018-945.

7. Arch Pediatr Adolesc Med. 2004;158(8):792-6.

8. Prev Med. 2018;113:7-12.

Long-acting injectables (LAIs) continue to be underused for patients with chronic diseases such as schizophrenia and bipolar disorder. However, in my practice, I have found the use of those medications to be useful for promoting adherence, and I wonder why they are not used more often – in light of their effectiveness. Specifically, among individuals with schizophrenia, LAIs can lead to significant improvements in symptom control, quality of life, and overall functioning.¹

The following three cases illustrate the power of LAIs:

Case 1: A male patient with schizoaffective diagnosis had been admitted several times to the inpatient psychiatric unit and had poor compliance to medications by mouth. He had multiple emergency department visits besides having community health behavioral support. After various medication trials by mouth, he responded to LAIs. He was able to function in the community for longer periods of time and required far fewer ED visits. He followed up with his outpatient psychiatric support regularly.

Case 2: A female patient with schizoaffective disorder had psychosis of a persecutory nature and paranoia. She was unable to function in the community and struggled with delusional thoughts leading to anger outbursts in the community. She continually refused medicines by mouth in the outpatient unit. Upon involuntary inpatient management as per court order, the patient responded to LAIs. Her insight improved, and she displayed better judgment in the future.

Case 3: A female patient with bipolar I was impulsive and promiscuous, and routinely entered into high-risk situations. She was not able to negotiate safely in the community, and was shuttling from shelter to shelter. She was losing her medications time and again during her transition in the community. She responded well to LAIs, however, and was able to keep herself out of the inpatient hospital for longer periods of time. She said she felt relieved about not depending on daily oral medications. She also reported not self medicating with street substances.

A recent retrospective study of more than 3,600 patients showed that those who initiate LAIs versus oral antipsychotics have greater reductions in the number of hospitalizations.² Furthermore, treatment with LAIs might be more cost-effective than oral medications, and might reduce the risk of suicide and the propensity to violence in at least a subset of individuals with psychotic illnesses and comorbid substance use disorders.^3,4

References

1. Kaplan G et al. Impact of long-acting injectable antipsychotics on medication adherence and clinical, functional, and economic outcomes of schizophrenia. Patient Prefer Adherence. 2013;13:1171-80.

2. Brissos S et al. The role of long-acting injectable antipsychotics in schizophrenia: a critical appraisal. Therapeutic advances in psychopharmacology. 2014 Oct;4(5):198-219.

3. Ravasio R et al. Analisi di costo-efficacia dello switch da un antipsicotico orale a risperidone a rilascio prolungato nel trattamento dei pazienti affetti da schizofrenia. Giorn Ital Health Technol Ass. 2019;2:1-8.

4. Reichhart T and W Kissling. Societal costs of nonadherence in schizophrenia: homicide/suicide. Mind & Brain, J Psychiatry. 2010 Aug 1(2):29-32.

5. Offord S et al. Health care resource usage of schizophrenia patients initiating long-acting injectable antipsychotics vs oral. J Med Econ. 2013;16:231-9.

6. Matthias J and W Rossler. Attitudes toward long-acting depot antipsychotics: a survey of patients, relatives and psychiatrists. Psychiatry Res. 2010 Jan 30;175(1-2):58-62.

Dr. Lamba, a psychiatrist and medical director at BayRidge Hospital in Lynn, Mass., has no disclosures. He changed key facts about the patients discussed to protect their confidentiality.

Long-acting injectables (LAIs) continue to be underused for patients with chronic diseases such as schizophrenia and bipolar disorder. However, in my practice, I have found the use of those medications to be useful for promoting adherence, and I wonder why they are not used more often – in light of their effectiveness. Specifically, among individuals with schizophrenia, LAIs can lead to significant improvements in symptom control, quality of life, and overall functioning.¹

The following three cases illustrate the power of LAIs:

Case 1: A male patient with schizoaffective diagnosis had been admitted several times to the inpatient psychiatric unit and had poor compliance to medications by mouth. He had multiple emergency department visits besides having community health behavioral support. After various medication trials by mouth, he responded to LAIs. He was able to function in the community for longer periods of time and required far fewer ED visits. He followed up with his outpatient psychiatric support regularly.

Case 2: A female patient with schizoaffective disorder had psychosis of a persecutory nature and paranoia. She was unable to function in the community and struggled with delusional thoughts leading to anger outbursts in the community. She continually refused medicines by mouth in the outpatient unit. Upon involuntary inpatient management as per court order, the patient responded to LAIs. Her insight improved, and she displayed better judgment in the future.

Case 3: A female patient with bipolar I was impulsive and promiscuous, and routinely entered into high-risk situations. She was not able to negotiate safely in the community, and was shuttling from shelter to shelter. She was losing her medications time and again during her transition in the community. She responded well to LAIs, however, and was able to keep herself out of the inpatient hospital for longer periods of time. She said she felt relieved about not depending on daily oral medications. She also reported not self medicating with street substances.

A recent retrospective study of more than 3,600 patients showed that those who initiate LAIs versus oral antipsychotics have greater reductions in the number of hospitalizations.² Furthermore, treatment with LAIs might be more cost-effective than oral medications, and might reduce the risk of suicide and the propensity to violence in at least a subset of individuals with psychotic illnesses and comorbid substance use disorders.^3,4

References

1. Kaplan G et al. Impact of long-acting injectable antipsychotics on medication adherence and clinical, functional, and economic outcomes of schizophrenia. Patient Prefer Adherence. 2013;13:1171-80.

2. Brissos S et al. The role of long-acting injectable antipsychotics in schizophrenia: a critical appraisal. Therapeutic advances in psychopharmacology. 2014 Oct;4(5):198-219.

3. Ravasio R et al. Analisi di costo-efficacia dello switch da un antipsicotico orale a risperidone a rilascio prolungato nel trattamento dei pazienti affetti da schizofrenia. Giorn Ital Health Technol Ass. 2019;2:1-8.

4. Reichhart T and W Kissling. Societal costs of nonadherence in schizophrenia: homicide/suicide. Mind & Brain, J Psychiatry. 2010 Aug 1(2):29-32.

5. Offord S et al. Health care resource usage of schizophrenia patients initiating long-acting injectable antipsychotics vs oral. J Med Econ. 2013;16:231-9.

6. Matthias J and W Rossler. Attitudes toward long-acting depot antipsychotics: a survey of patients, relatives and psychiatrists. Psychiatry Res. 2010 Jan 30;175(1-2):58-62.

Dr. Lamba, a psychiatrist and medical director at BayRidge Hospital in Lynn, Mass., has no disclosures. He changed key facts about the patients discussed to protect their confidentiality.

Long-acting injectables (LAIs) continue to be underused for patients with chronic diseases such as schizophrenia and bipolar disorder. However, in my practice, I have found the use of those medications to be useful for promoting adherence, and I wonder why they are not used more often – in light of their effectiveness. Specifically, among individuals with schizophrenia, LAIs can lead to significant improvements in symptom control, quality of life, and overall functioning.¹

The following three cases illustrate the power of LAIs:

Case 1: A male patient with schizoaffective diagnosis had been admitted several times to the inpatient psychiatric unit and had poor compliance to medications by mouth. He had multiple emergency department visits besides having community health behavioral support. After various medication trials by mouth, he responded to LAIs. He was able to function in the community for longer periods of time and required far fewer ED visits. He followed up with his outpatient psychiatric support regularly.

Case 2: A female patient with schizoaffective disorder had psychosis of a persecutory nature and paranoia. She was unable to function in the community and struggled with delusional thoughts leading to anger outbursts in the community. She continually refused medicines by mouth in the outpatient unit. Upon involuntary inpatient management as per court order, the patient responded to LAIs. Her insight improved, and she displayed better judgment in the future.

Case 3: A female patient with bipolar I was impulsive and promiscuous, and routinely entered into high-risk situations. She was not able to negotiate safely in the community, and was shuttling from shelter to shelter. She was losing her medications time and again during her transition in the community. She responded well to LAIs, however, and was able to keep herself out of the inpatient hospital for longer periods of time. She said she felt relieved about not depending on daily oral medications. She also reported not self medicating with street substances.

A recent retrospective study of more than 3,600 patients showed that those who initiate LAIs versus oral antipsychotics have greater reductions in the number of hospitalizations.² Furthermore, treatment with LAIs might be more cost-effective than oral medications, and might reduce the risk of suicide and the propensity to violence in at least a subset of individuals with psychotic illnesses and comorbid substance use disorders.^3,4

References

1. Kaplan G et al. Impact of long-acting injectable antipsychotics on medication adherence and clinical, functional, and economic outcomes of schizophrenia. Patient Prefer Adherence. 2013;13:1171-80.

2. Brissos S et al. The role of long-acting injectable antipsychotics in schizophrenia: a critical appraisal. Therapeutic advances in psychopharmacology. 2014 Oct;4(5):198-219.

3. Ravasio R et al. Analisi di costo-efficacia dello switch da un antipsicotico orale a risperidone a rilascio prolungato nel trattamento dei pazienti affetti da schizofrenia. Giorn Ital Health Technol Ass. 2019;2:1-8.

4. Reichhart T and W Kissling. Societal costs of nonadherence in schizophrenia: homicide/suicide. Mind & Brain, J Psychiatry. 2010 Aug 1(2):29-32.

5. Offord S et al. Health care resource usage of schizophrenia patients initiating long-acting injectable antipsychotics vs oral. J Med Econ. 2013;16:231-9.

6. Matthias J and W Rossler. Attitudes toward long-acting depot antipsychotics: a survey of patients, relatives and psychiatrists. Psychiatry Res. 2010 Jan 30;175(1-2):58-62.

Dr. Lamba, a psychiatrist and medical director at BayRidge Hospital in Lynn, Mass., has no disclosures. He changed key facts about the patients discussed to protect their confidentiality.

Adults with asthma–chronic obstructive pulmonary disease overlap syndrome who took statins had lower rates of anxiety and depression than did those not on statins, based on data from approximately 9,000 patients.

Although asthma–COPD overlap syndrome (ACOS) has been associated with depression, the effects of oral and inhaled corticosteroids on anxiety and depression in these patients have not been well investigated, wrote Jun-Jun Yeh, MD, of Ditmanson Medical Foundation Chia-Yi (Taiwan) Christian Hospital, and colleagues.

In a study published in the Journal of Affective Disorders, the researchers analyzed 9,139 ACOS patients including 1,252 statin users and 7,887 nonstatin users; 62% were male.

The statin users had significantly lower risk of both anxiety and depression than did the nonstatin users (adjusted hazard ratio 0.34 for anxiety and 0.36 for depression) after researchers controlled for factors including age, sex, comorbidities, and medications. Statin users experienced a total of 109 anxiety or depression events over an average of 8 years’ follow-up, while nonstatin users experienced a total of 1,333 anxiety or depression events over an average of 5 years’ follow-up.

The incidence density rate of anxiety was 11/1,000 person-years for statin users and 33/1,000 person-years for nonstatin users. The incidence density rate of depression was 3/1,000 person-years for statin users and 9/1,000 person-years for nonstatin users.

Significantly lower risk of anxiety and depression also were observed in statin users, compared with nonstatin users, in subgroups of men, women, patients younger than 50 years, and patients aged 50 years and older. The risks of anxiety and depression were lower in statin users versus nonstatin users across all subgroups with or without inhaled or oral corticosteroids.

Overall, the statin users were significantly younger, had more comorbidities, and were more likely to use inhaled or oral corticosteroids than were the nonstatin users.

The findings were limited by several factors including the retrospective nature of the study and a lack of information on prescribed daily doses of medication, the researchers noted. However, the results support those from previous studies and suggest that “the anti-inflammatory effect of statins may attenuate anxiety and depression in ACOS patients, even in the late stages of the disease,” although the exact mechanism of action remains unknown and larger, randomized, controlled trials are needed, they said.

The study was supported by grants from a variety of organizations in Taiwan, China, and Japan. The researchers had no financial conflicts to disclose.

SOURCE: Yeh JJ et al. J Affect Disord. 2019 Jun 15; 253:277-84.

Adults with asthma–chronic obstructive pulmonary disease overlap syndrome who took statins had lower rates of anxiety and depression than did those not on statins, based on data from approximately 9,000 patients.

Although asthma–COPD overlap syndrome (ACOS) has been associated with depression, the effects of oral and inhaled corticosteroids on anxiety and depression in these patients have not been well investigated, wrote Jun-Jun Yeh, MD, of Ditmanson Medical Foundation Chia-Yi (Taiwan) Christian Hospital, and colleagues.

In a study published in the Journal of Affective Disorders, the researchers analyzed 9,139 ACOS patients including 1,252 statin users and 7,887 nonstatin users; 62% were male.

The statin users had significantly lower risk of both anxiety and depression than did the nonstatin users (adjusted hazard ratio 0.34 for anxiety and 0.36 for depression) after researchers controlled for factors including age, sex, comorbidities, and medications. Statin users experienced a total of 109 anxiety or depression events over an average of 8 years’ follow-up, while nonstatin users experienced a total of 1,333 anxiety or depression events over an average of 5 years’ follow-up.

The incidence density rate of anxiety was 11/1,000 person-years for statin users and 33/1,000 person-years for nonstatin users. The incidence density rate of depression was 3/1,000 person-years for statin users and 9/1,000 person-years for nonstatin users.

Significantly lower risk of anxiety and depression also were observed in statin users, compared with nonstatin users, in subgroups of men, women, patients younger than 50 years, and patients aged 50 years and older. The risks of anxiety and depression were lower in statin users versus nonstatin users across all subgroups with or without inhaled or oral corticosteroids.

Overall, the statin users were significantly younger, had more comorbidities, and were more likely to use inhaled or oral corticosteroids than were the nonstatin users.

The findings were limited by several factors including the retrospective nature of the study and a lack of information on prescribed daily doses of medication, the researchers noted. However, the results support those from previous studies and suggest that “the anti-inflammatory effect of statins may attenuate anxiety and depression in ACOS patients, even in the late stages of the disease,” although the exact mechanism of action remains unknown and larger, randomized, controlled trials are needed, they said.

The study was supported by grants from a variety of organizations in Taiwan, China, and Japan. The researchers had no financial conflicts to disclose.

SOURCE: Yeh JJ et al. J Affect Disord. 2019 Jun 15; 253:277-84.

Adults with asthma–chronic obstructive pulmonary disease overlap syndrome who took statins had lower rates of anxiety and depression than did those not on statins, based on data from approximately 9,000 patients.

Although asthma–COPD overlap syndrome (ACOS) has been associated with depression, the effects of oral and inhaled corticosteroids on anxiety and depression in these patients have not been well investigated, wrote Jun-Jun Yeh, MD, of Ditmanson Medical Foundation Chia-Yi (Taiwan) Christian Hospital, and colleagues.

In a study published in the Journal of Affective Disorders, the researchers analyzed 9,139 ACOS patients including 1,252 statin users and 7,887 nonstatin users; 62% were male.

The statin users had significantly lower risk of both anxiety and depression than did the nonstatin users (adjusted hazard ratio 0.34 for anxiety and 0.36 for depression) after researchers controlled for factors including age, sex, comorbidities, and medications. Statin users experienced a total of 109 anxiety or depression events over an average of 8 years’ follow-up, while nonstatin users experienced a total of 1,333 anxiety or depression events over an average of 5 years’ follow-up.

The incidence density rate of anxiety was 11/1,000 person-years for statin users and 33/1,000 person-years for nonstatin users. The incidence density rate of depression was 3/1,000 person-years for statin users and 9/1,000 person-years for nonstatin users.

Significantly lower risk of anxiety and depression also were observed in statin users, compared with nonstatin users, in subgroups of men, women, patients younger than 50 years, and patients aged 50 years and older. The risks of anxiety and depression were lower in statin users versus nonstatin users across all subgroups with or without inhaled or oral corticosteroids.

Overall, the statin users were significantly younger, had more comorbidities, and were more likely to use inhaled or oral corticosteroids than were the nonstatin users.

The findings were limited by several factors including the retrospective nature of the study and a lack of information on prescribed daily doses of medication, the researchers noted. However, the results support those from previous studies and suggest that “the anti-inflammatory effect of statins may attenuate anxiety and depression in ACOS patients, even in the late stages of the disease,” although the exact mechanism of action remains unknown and larger, randomized, controlled trials are needed, they said.

The study was supported by grants from a variety of organizations in Taiwan, China, and Japan. The researchers had no financial conflicts to disclose.

SOURCE: Yeh JJ et al. J Affect Disord. 2019 Jun 15; 253:277-84.

Adding the immune checkpoint inhibitor atezolizumab (Tecentriq) to doublet or triplet regimens as first-line treatment for nonsquamous non–small cell lung cancer (NSCLC) is not cost effective, even by a long shot, concluded a Markov modeling study.

Positive results of the IMpower150 trial led the Food and Drug Administration to approve and the National Comprehensive Cancer Network to recommend the combination of atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) as an option for selected patients in this setting, noted the investigators, led by XiaoMin Wan, PhD, of the department of pharmacy at the Second Xiangya Hospital and the Institute of Clinical Pharmacy, both at Central South University, Changsha, China.

“Although adding atezolizumab to the combination of bevacizumab and chemotherapy results in significantly higher survival in patients with metastatic NSCLC, the question of whether its price reflects its potential benefit remains unclear from a value standpoint,” they wrote.

Dr. Wan and colleagues developed a Markov model to compare the lifetime cost and effectiveness of various combinations – the quadruplet ABCP regimen, the triplet BCP regimen (bevacizumab, carboplatin, and paclitaxel), and the doublet CP regimen (carboplatin and paclitaxel) – when used as first‐line treatment for metastatic nonsquamous NSCLC.

ABCP yielded an additional 0.413 quality-adjusted life-years (QALYs) and 0.460 life-years, compared with BCP, and an additional 0.738 QALYs and 0.956 life-years, compared with CP. Respective incremental costs were $234,998 and $381,116, the investigators reported in Cancer.

Ultimately, ABCP had an incremental cost‐effectiveness ratio (ICER) of $568,967 per QALY, compared with BCP, and $516,114 per QALY, compared with CP – both of which far exceeded the conventional $100,000 ICER per QALY willingness-to-pay threshold.

Although atezolizumab targets programmed death–ligand 1 (PD-L1), the ICER improved only modestly to $464,703 per QALY when treatment was given only to patients having PD‐L1 expression of at least 50% on tumor cells or at least 10% on immune cells. Findings were similar when the duration of atezolizumab therapy was restricted to 2 years.

However, steep reductions in the costs of the two targeted agents altered results. Specifically, ABCP had an ICER of $99,786 and $162,441 per QALY, compared with BCP and CP, respectively, when the costs of atezolizumab and bevacizumab were reduced by 70%, and ABCP fell below the $100,000 willingness-to-pay threshold, compared with both regimens, when those costs were reduced by 83%.

“To our knowledge, the current study is the first cost-effectiveness analysis of ABCP, compared with BCP, in the first-line setting for patients with metastatic NSCLC,” Dr. Wan and colleagues noted. “From the perspective of the U.S. payer, ABCP is estimated not to be cost effective, compared with BCP or CP, in the first-line setting for patients with metastatic, nonsquamous NSCLC at a [willingness-to-pay] threshold of $100,000 per QALY.”

“Although ABCP is not considered to be cost effective, this does not mean that patients should receive the less-effective treatment strategy of BCP,” they cautioned, noting that recent cost-effectiveness data appear to favor the first-line combination of another immune checkpoint inhibitor, pembrolizumab (Keytruda), with chemotherapy instead. “A price reduction is warranted to make ABCP cost effective and affordable.”

Dr. Wan did not report any relevant conflicts of interest. The study was supported by grants from the National Natural Science Foundation of China and the research project of the Health and Family Planning Commission of Hunan province.

SOURCE: Wan X et al. Cancer. 2019 Jul 9. doi: 10.1002/cncr.32368.

Adding the immune checkpoint inhibitor atezolizumab (Tecentriq) to doublet or triplet regimens as first-line treatment for nonsquamous non–small cell lung cancer (NSCLC) is not cost effective, even by a long shot, concluded a Markov modeling study.

Positive results of the IMpower150 trial led the Food and Drug Administration to approve and the National Comprehensive Cancer Network to recommend the combination of atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) as an option for selected patients in this setting, noted the investigators, led by XiaoMin Wan, PhD, of the department of pharmacy at the Second Xiangya Hospital and the Institute of Clinical Pharmacy, both at Central South University, Changsha, China.

“Although adding atezolizumab to the combination of bevacizumab and chemotherapy results in significantly higher survival in patients with metastatic NSCLC, the question of whether its price reflects its potential benefit remains unclear from a value standpoint,” they wrote.

Dr. Wan and colleagues developed a Markov model to compare the lifetime cost and effectiveness of various combinations – the quadruplet ABCP regimen, the triplet BCP regimen (bevacizumab, carboplatin, and paclitaxel), and the doublet CP regimen (carboplatin and paclitaxel) – when used as first‐line treatment for metastatic nonsquamous NSCLC.

ABCP yielded an additional 0.413 quality-adjusted life-years (QALYs) and 0.460 life-years, compared with BCP, and an additional 0.738 QALYs and 0.956 life-years, compared with CP. Respective incremental costs were $234,998 and $381,116, the investigators reported in Cancer.

Ultimately, ABCP had an incremental cost‐effectiveness ratio (ICER) of $568,967 per QALY, compared with BCP, and $516,114 per QALY, compared with CP – both of which far exceeded the conventional $100,000 ICER per QALY willingness-to-pay threshold.

Although atezolizumab targets programmed death–ligand 1 (PD-L1), the ICER improved only modestly to $464,703 per QALY when treatment was given only to patients having PD‐L1 expression of at least 50% on tumor cells or at least 10% on immune cells. Findings were similar when the duration of atezolizumab therapy was restricted to 2 years.

However, steep reductions in the costs of the two targeted agents altered results. Specifically, ABCP had an ICER of $99,786 and $162,441 per QALY, compared with BCP and CP, respectively, when the costs of atezolizumab and bevacizumab were reduced by 70%, and ABCP fell below the $100,000 willingness-to-pay threshold, compared with both regimens, when those costs were reduced by 83%.

“To our knowledge, the current study is the first cost-effectiveness analysis of ABCP, compared with BCP, in the first-line setting for patients with metastatic NSCLC,” Dr. Wan and colleagues noted. “From the perspective of the U.S. payer, ABCP is estimated not to be cost effective, compared with BCP or CP, in the first-line setting for patients with metastatic, nonsquamous NSCLC at a [willingness-to-pay] threshold of $100,000 per QALY.”

“Although ABCP is not considered to be cost effective, this does not mean that patients should receive the less-effective treatment strategy of BCP,” they cautioned, noting that recent cost-effectiveness data appear to favor the first-line combination of another immune checkpoint inhibitor, pembrolizumab (Keytruda), with chemotherapy instead. “A price reduction is warranted to make ABCP cost effective and affordable.”

Dr. Wan did not report any relevant conflicts of interest. The study was supported by grants from the National Natural Science Foundation of China and the research project of the Health and Family Planning Commission of Hunan province.

SOURCE: Wan X et al. Cancer. 2019 Jul 9. doi: 10.1002/cncr.32368.

Adding the immune checkpoint inhibitor atezolizumab (Tecentriq) to doublet or triplet regimens as first-line treatment for nonsquamous non–small cell lung cancer (NSCLC) is not cost effective, even by a long shot, concluded a Markov modeling study.

Positive results of the IMpower150 trial led the Food and Drug Administration to approve and the National Comprehensive Cancer Network to recommend the combination of atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) as an option for selected patients in this setting, noted the investigators, led by XiaoMin Wan, PhD, of the department of pharmacy at the Second Xiangya Hospital and the Institute of Clinical Pharmacy, both at Central South University, Changsha, China.

“Although adding atezolizumab to the combination of bevacizumab and chemotherapy results in significantly higher survival in patients with metastatic NSCLC, the question of whether its price reflects its potential benefit remains unclear from a value standpoint,” they wrote.

Dr. Wan and colleagues developed a Markov model to compare the lifetime cost and effectiveness of various combinations – the quadruplet ABCP regimen, the triplet BCP regimen (bevacizumab, carboplatin, and paclitaxel), and the doublet CP regimen (carboplatin and paclitaxel) – when used as first‐line treatment for metastatic nonsquamous NSCLC.

ABCP yielded an additional 0.413 quality-adjusted life-years (QALYs) and 0.460 life-years, compared with BCP, and an additional 0.738 QALYs and 0.956 life-years, compared with CP. Respective incremental costs were $234,998 and $381,116, the investigators reported in Cancer.

Ultimately, ABCP had an incremental cost‐effectiveness ratio (ICER) of $568,967 per QALY, compared with BCP, and $516,114 per QALY, compared with CP – both of which far exceeded the conventional $100,000 ICER per QALY willingness-to-pay threshold.

Although atezolizumab targets programmed death–ligand 1 (PD-L1), the ICER improved only modestly to $464,703 per QALY when treatment was given only to patients having PD‐L1 expression of at least 50% on tumor cells or at least 10% on immune cells. Findings were similar when the duration of atezolizumab therapy was restricted to 2 years.

However, steep reductions in the costs of the two targeted agents altered results. Specifically, ABCP had an ICER of $99,786 and $162,441 per QALY, compared with BCP and CP, respectively, when the costs of atezolizumab and bevacizumab were reduced by 70%, and ABCP fell below the $100,000 willingness-to-pay threshold, compared with both regimens, when those costs were reduced by 83%.

“To our knowledge, the current study is the first cost-effectiveness analysis of ABCP, compared with BCP, in the first-line setting for patients with metastatic NSCLC,” Dr. Wan and colleagues noted. “From the perspective of the U.S. payer, ABCP is estimated not to be cost effective, compared with BCP or CP, in the first-line setting for patients with metastatic, nonsquamous NSCLC at a [willingness-to-pay] threshold of $100,000 per QALY.”

“Although ABCP is not considered to be cost effective, this does not mean that patients should receive the less-effective treatment strategy of BCP,” they cautioned, noting that recent cost-effectiveness data appear to favor the first-line combination of another immune checkpoint inhibitor, pembrolizumab (Keytruda), with chemotherapy instead. “A price reduction is warranted to make ABCP cost effective and affordable.”

Dr. Wan did not report any relevant conflicts of interest. The study was supported by grants from the National Natural Science Foundation of China and the research project of the Health and Family Planning Commission of Hunan province.

SOURCE: Wan X et al. Cancer. 2019 Jul 9. doi: 10.1002/cncr.32368.

Non–vitamin K oral anticoagulants (NOACs) significantly reduced the risk of stroke or systemic embolism compared to vitamin K antagonists (VKAs) for patients in the early stages of chronic kidney disease and comorbid atrial fibrillation, based on data from a meta-analysis of roughly 34,000 patients.

Chronic kidney disease increases the risk of complications including stroke, congestive heart failure, and death in patients who also have atrial fibrillation, but most trials of anticoagulant therapy to reduce the risk of such events have excluded these patients, wrote Jeffrey T. Ha, MBBS, of the George Institute for Global Health, Newtown, Australia, and colleagues.

To assess the benefits and harms of oral anticoagulants for multiple indications in chronic kidney disease patients, the researchers conducted a meta-analysis of 45 studies including 34,082 individuals. The findings were published in the Annals of Internal Medicine. The analysis included 8 trials of end stage kidney disease patients on dialysis; the remaining trials excluded patients with creatinine clearance less than 20 mL/min or an estimated glomerular filtration rate less than 15 mL/min per 1.73 m². The interventional agents were rivaroxaban, dabigatran, apixaban, edoxaban, betrixaban, warfarin, and acenocoumarol.

A notable finding was the significant reduction in relative risk of stroke or systemic embolism (21%), hemorrhagic stroke (52%), and intracranial hemorrhage (51%) for early-stage chronic kidney disease patients with atrial fibrillation given NOACs, compared with those given VKAs.

The evidence for the superiority of NOACs over VKAs for reducing risk of venous thromboembolism (VTE) or VTE-related death was uncertain, as was the evidence to draw any conclusions about benefits and harms of either NOACs or VKAs for patients with advanced or end-stage kidney disease.

Across all trials, NOACs appeared to reduce the relative risk of major bleeding, compared with VKAs by roughly 25%, but the difference was not statistically significant, the researchers noted.

The findings were limited by the lack of evidence for oral anticoagulant use in patients with advanced chronic or end-stage kidney disease, as well as inability to assess differences among NOACs, the researchers noted. However, the results suggest that NOACs may be recommended over VKAs for the subgroup of early-stage chronic kidney disease patients with atrial fibrillation, they said.

Several additional trials are in progress, and future trials “should include not only participants with dialysis-dependent ESKD [end-stage kidney disease] but also those with CrCl [creatinine clearance of] less than 25 mL/min,” and compare NOACs with placebo as well, they noted.

Lead author Dr. Ha is supported by a University Postgraduate Award from University of New South Wales, Sydney, but had no financial conflicts to disclose; coauthors disclosed support from various organizations as well as pharmaceutical companies including Baxter, Amgen, Eli Lilly, Boehringer Ingelheim, Vifor Pharma, Janssen, Pfizer, Bristol-Myers Squibb, and GlaxoSmithKline.
 

SOURCE: Ha JT et al. Ann Intern Med. 2019 July 15. doi: 10.7326/M19-0087

Non–vitamin K oral anticoagulants (NOACs) significantly reduced the risk of stroke or systemic embolism compared to vitamin K antagonists (VKAs) for patients in the early stages of chronic kidney disease and comorbid atrial fibrillation, based on data from a meta-analysis of roughly 34,000 patients.

Chronic kidney disease increases the risk of complications including stroke, congestive heart failure, and death in patients who also have atrial fibrillation, but most trials of anticoagulant therapy to reduce the risk of such events have excluded these patients, wrote Jeffrey T. Ha, MBBS, of the George Institute for Global Health, Newtown, Australia, and colleagues.

To assess the benefits and harms of oral anticoagulants for multiple indications in chronic kidney disease patients, the researchers conducted a meta-analysis of 45 studies including 34,082 individuals. The findings were published in the Annals of Internal Medicine. The analysis included 8 trials of end stage kidney disease patients on dialysis; the remaining trials excluded patients with creatinine clearance less than 20 mL/min or an estimated glomerular filtration rate less than 15 mL/min per 1.73 m². The interventional agents were rivaroxaban, dabigatran, apixaban, edoxaban, betrixaban, warfarin, and acenocoumarol.

A notable finding was the significant reduction in relative risk of stroke or systemic embolism (21%), hemorrhagic stroke (52%), and intracranial hemorrhage (51%) for early-stage chronic kidney disease patients with atrial fibrillation given NOACs, compared with those given VKAs.

The evidence for the superiority of NOACs over VKAs for reducing risk of venous thromboembolism (VTE) or VTE-related death was uncertain, as was the evidence to draw any conclusions about benefits and harms of either NOACs or VKAs for patients with advanced or end-stage kidney disease.

Across all trials, NOACs appeared to reduce the relative risk of major bleeding, compared with VKAs by roughly 25%, but the difference was not statistically significant, the researchers noted.

The findings were limited by the lack of evidence for oral anticoagulant use in patients with advanced chronic or end-stage kidney disease, as well as inability to assess differences among NOACs, the researchers noted. However, the results suggest that NOACs may be recommended over VKAs for the subgroup of early-stage chronic kidney disease patients with atrial fibrillation, they said.

Several additional trials are in progress, and future trials “should include not only participants with dialysis-dependent ESKD [end-stage kidney disease] but also those with CrCl [creatinine clearance of] less than 25 mL/min,” and compare NOACs with placebo as well, they noted.

Lead author Dr. Ha is supported by a University Postgraduate Award from University of New South Wales, Sydney, but had no financial conflicts to disclose; coauthors disclosed support from various organizations as well as pharmaceutical companies including Baxter, Amgen, Eli Lilly, Boehringer Ingelheim, Vifor Pharma, Janssen, Pfizer, Bristol-Myers Squibb, and GlaxoSmithKline.
 

SOURCE: Ha JT et al. Ann Intern Med. 2019 July 15. doi: 10.7326/M19-0087

Non–vitamin K oral anticoagulants (NOACs) significantly reduced the risk of stroke or systemic embolism compared to vitamin K antagonists (VKAs) for patients in the early stages of chronic kidney disease and comorbid atrial fibrillation, based on data from a meta-analysis of roughly 34,000 patients.

Chronic kidney disease increases the risk of complications including stroke, congestive heart failure, and death in patients who also have atrial fibrillation, but most trials of anticoagulant therapy to reduce the risk of such events have excluded these patients, wrote Jeffrey T. Ha, MBBS, of the George Institute for Global Health, Newtown, Australia, and colleagues.

To assess the benefits and harms of oral anticoagulants for multiple indications in chronic kidney disease patients, the researchers conducted a meta-analysis of 45 studies including 34,082 individuals. The findings were published in the Annals of Internal Medicine. The analysis included 8 trials of end stage kidney disease patients on dialysis; the remaining trials excluded patients with creatinine clearance less than 20 mL/min or an estimated glomerular filtration rate less than 15 mL/min per 1.73 m². The interventional agents were rivaroxaban, dabigatran, apixaban, edoxaban, betrixaban, warfarin, and acenocoumarol.

A notable finding was the significant reduction in relative risk of stroke or systemic embolism (21%), hemorrhagic stroke (52%), and intracranial hemorrhage (51%) for early-stage chronic kidney disease patients with atrial fibrillation given NOACs, compared with those given VKAs.

The evidence for the superiority of NOACs over VKAs for reducing risk of venous thromboembolism (VTE) or VTE-related death was uncertain, as was the evidence to draw any conclusions about benefits and harms of either NOACs or VKAs for patients with advanced or end-stage kidney disease.

Across all trials, NOACs appeared to reduce the relative risk of major bleeding, compared with VKAs by roughly 25%, but the difference was not statistically significant, the researchers noted.

The findings were limited by the lack of evidence for oral anticoagulant use in patients with advanced chronic or end-stage kidney disease, as well as inability to assess differences among NOACs, the researchers noted. However, the results suggest that NOACs may be recommended over VKAs for the subgroup of early-stage chronic kidney disease patients with atrial fibrillation, they said.

Several additional trials are in progress, and future trials “should include not only participants with dialysis-dependent ESKD [end-stage kidney disease] but also those with CrCl [creatinine clearance of] less than 25 mL/min,” and compare NOACs with placebo as well, they noted.

Lead author Dr. Ha is supported by a University Postgraduate Award from University of New South Wales, Sydney, but had no financial conflicts to disclose; coauthors disclosed support from various organizations as well as pharmaceutical companies including Baxter, Amgen, Eli Lilly, Boehringer Ingelheim, Vifor Pharma, Janssen, Pfizer, Bristol-Myers Squibb, and GlaxoSmithKline.
 

SOURCE: Ha JT et al. Ann Intern Med. 2019 July 15. doi: 10.7326/M19-0087

Cold snare polypectomy with continuous administration of anticoagulants results in less bleeding, shorter procedure time, and shorter time in hospital in patients with colon polyps taking anticoagulants compared with hot snare polypectomy with periprocedural heparin bridging, according to recent research published in the Annals of Internal Medicine.

“Guidelines on peripolypectomy management of anticoagulants vary greatly, and the current updated guidelines do not recommend heparin bridging (HB) for all patients; however, direct comparison of HB with continuous administration of oral anticoagulants (CA) has provided little evidence,” Yoji Takeuchi, MD, from the Department of Gastrointestinal Oncology at Osaka International Cancer Institute in Osaka, Japan, and colleagues wrote.

While cold snare polypectomy (CSP) has been recommended by the European Society of Gastrointestinal Endoscopy for subcentimeter polyps, anticoagulant delivery method has not been studied between these two poly removal methods. “Cold snare polypectomy with CA may be performed safely, without the complications of HB, while theoretically maintaining an anticoagulant effect,” the researchers said.

Dr. Takeuchi and colleagues performed a randomized controlled trial of 182 patients with subcentimeter colorectal polyps who underwent either CA with CSP (CA+CSP; 92 patients) or hot snare polypectomy (HSP) with HB (HB+HSP; 90 patients) at one of 30 different Japanese centers. Patients were between 20 and 80 years old and had preserved organ function, an Eastern Cooperative Oncology Group Performance Status score of 1 or less, and were taking warfarin or a direct oral anticoagulant (DOAC) such as dabigatran, rivaroxaban, apixaban, or edoxaban. Researchers assessed the level of bleeding at 28-day follow-up, and also measured procedure time per polyp and length of hospital stay for each group.

Overall, there were 611 polyps removed in 168 patients. The rate of major bleeding in the CA+CSP group was 4.7% (95% confidence interval [CI], 0.2%-9.2%) compared with 12.0% (95% CI, 5.0%-19.1%) in the HB+HSP group with an intergroup difference of 7.3% (95% CI, 1.0%-15.7%).

“[T]he Japanese guidelines consider all patients receiving anticoagulants to be at high risk for thromboembolism associated with antithrombotic withdrawal,” Dr. Takeuchi and colleagues said. “Our results suggest that discontinuing anticoagulant therapy before polypectomy for subcentimeter polyps may be unnecessary and support the Japanese guidelines, which recommend not withholding anticoagulants for procedures with low bleeding risk.”

The researchers declared CA+CSP to be non-inferior with a 0.4% lower limit of 2-sided 90% CI. “[W]e noted a higher number of total and right-sided polyps in the CA+CSP group, both of which may result in more frequent bleeding episodes, which suggests that CA+CSP may be a relatively safe approach,” the researchers said. “Therefore, we think that CSP may be the least risky polypectomy procedure.”

The mean procedure time per polyp was 59.6 seconds in the CA+CSP group (54.0-65.2 seconds) compared with 94.4 seconds in the HB+HSP group (87.1-101.7 seconds; P less than .001). Mean hospital stay for patients in the CA+CSP group was shorter at 2.9 days (1.8-4.0 days) compared with 5.1 days in the HB+HSP group (4.2-6.1 days; P equals .003).

The study examined patients receiving two different anticoagulant delivery methods and polyp removal procedures, which made it difficult to determine which intervention contributed to the results, the researchers said. In addition, the study was not blinded and polyp type was limited to only subcentimeter polyps.

“Although CA+CSP is considered standard treatment for subcentimeter colorectal polyps in patients receiving anticoagulants, a larger trial is needed to identify a better management strategy for patients receiving DOACs,” the researchers said.

This study was supported by a grant from the Japanese Gastroenterological Association. The authors report no relevant conflicts of interest.

SOURCE: Takeuchi Y et al. Ann Intern Med. 2019;doi: 10.7326/M19-0026 .

Cold snare polypectomy with continuous administration of anticoagulants results in less bleeding, shorter procedure time, and shorter time in hospital in patients with colon polyps taking anticoagulants compared with hot snare polypectomy with periprocedural heparin bridging, according to recent research published in the Annals of Internal Medicine.

“Guidelines on peripolypectomy management of anticoagulants vary greatly, and the current updated guidelines do not recommend heparin bridging (HB) for all patients; however, direct comparison of HB with continuous administration of oral anticoagulants (CA) has provided little evidence,” Yoji Takeuchi, MD, from the Department of Gastrointestinal Oncology at Osaka International Cancer Institute in Osaka, Japan, and colleagues wrote.

While cold snare polypectomy (CSP) has been recommended by the European Society of Gastrointestinal Endoscopy for subcentimeter polyps, anticoagulant delivery method has not been studied between these two poly removal methods. “Cold snare polypectomy with CA may be performed safely, without the complications of HB, while theoretically maintaining an anticoagulant effect,” the researchers said.

Dr. Takeuchi and colleagues performed a randomized controlled trial of 182 patients with subcentimeter colorectal polyps who underwent either CA with CSP (CA+CSP; 92 patients) or hot snare polypectomy (HSP) with HB (HB+HSP; 90 patients) at one of 30 different Japanese centers. Patients were between 20 and 80 years old and had preserved organ function, an Eastern Cooperative Oncology Group Performance Status score of 1 or less, and were taking warfarin or a direct oral anticoagulant (DOAC) such as dabigatran, rivaroxaban, apixaban, or edoxaban. Researchers assessed the level of bleeding at 28-day follow-up, and also measured procedure time per polyp and length of hospital stay for each group.

Overall, there were 611 polyps removed in 168 patients. The rate of major bleeding in the CA+CSP group was 4.7% (95% confidence interval [CI], 0.2%-9.2%) compared with 12.0% (95% CI, 5.0%-19.1%) in the HB+HSP group with an intergroup difference of 7.3% (95% CI, 1.0%-15.7%).

“[T]he Japanese guidelines consider all patients receiving anticoagulants to be at high risk for thromboembolism associated with antithrombotic withdrawal,” Dr. Takeuchi and colleagues said. “Our results suggest that discontinuing anticoagulant therapy before polypectomy for subcentimeter polyps may be unnecessary and support the Japanese guidelines, which recommend not withholding anticoagulants for procedures with low bleeding risk.”

The researchers declared CA+CSP to be non-inferior with a 0.4% lower limit of 2-sided 90% CI. “[W]e noted a higher number of total and right-sided polyps in the CA+CSP group, both of which may result in more frequent bleeding episodes, which suggests that CA+CSP may be a relatively safe approach,” the researchers said. “Therefore, we think that CSP may be the least risky polypectomy procedure.”

The mean procedure time per polyp was 59.6 seconds in the CA+CSP group (54.0-65.2 seconds) compared with 94.4 seconds in the HB+HSP group (87.1-101.7 seconds; P less than .001). Mean hospital stay for patients in the CA+CSP group was shorter at 2.9 days (1.8-4.0 days) compared with 5.1 days in the HB+HSP group (4.2-6.1 days; P equals .003).

The study examined patients receiving two different anticoagulant delivery methods and polyp removal procedures, which made it difficult to determine which intervention contributed to the results, the researchers said. In addition, the study was not blinded and polyp type was limited to only subcentimeter polyps.

“Although CA+CSP is considered standard treatment for subcentimeter colorectal polyps in patients receiving anticoagulants, a larger trial is needed to identify a better management strategy for patients receiving DOACs,” the researchers said.

This study was supported by a grant from the Japanese Gastroenterological Association. The authors report no relevant conflicts of interest.

SOURCE: Takeuchi Y et al. Ann Intern Med. 2019;doi: 10.7326/M19-0026 .

Cold snare polypectomy with continuous administration of anticoagulants results in less bleeding, shorter procedure time, and shorter time in hospital in patients with colon polyps taking anticoagulants compared with hot snare polypectomy with periprocedural heparin bridging, according to recent research published in the Annals of Internal Medicine.

“Guidelines on peripolypectomy management of anticoagulants vary greatly, and the current updated guidelines do not recommend heparin bridging (HB) for all patients; however, direct comparison of HB with continuous administration of oral anticoagulants (CA) has provided little evidence,” Yoji Takeuchi, MD, from the Department of Gastrointestinal Oncology at Osaka International Cancer Institute in Osaka, Japan, and colleagues wrote.

While cold snare polypectomy (CSP) has been recommended by the European Society of Gastrointestinal Endoscopy for subcentimeter polyps, anticoagulant delivery method has not been studied between these two poly removal methods. “Cold snare polypectomy with CA may be performed safely, without the complications of HB, while theoretically maintaining an anticoagulant effect,” the researchers said.

Dr. Takeuchi and colleagues performed a randomized controlled trial of 182 patients with subcentimeter colorectal polyps who underwent either CA with CSP (CA+CSP; 92 patients) or hot snare polypectomy (HSP) with HB (HB+HSP; 90 patients) at one of 30 different Japanese centers. Patients were between 20 and 80 years old and had preserved organ function, an Eastern Cooperative Oncology Group Performance Status score of 1 or less, and were taking warfarin or a direct oral anticoagulant (DOAC) such as dabigatran, rivaroxaban, apixaban, or edoxaban. Researchers assessed the level of bleeding at 28-day follow-up, and also measured procedure time per polyp and length of hospital stay for each group.

Overall, there were 611 polyps removed in 168 patients. The rate of major bleeding in the CA+CSP group was 4.7% (95% confidence interval [CI], 0.2%-9.2%) compared with 12.0% (95% CI, 5.0%-19.1%) in the HB+HSP group with an intergroup difference of 7.3% (95% CI, 1.0%-15.7%).

“[T]he Japanese guidelines consider all patients receiving anticoagulants to be at high risk for thromboembolism associated with antithrombotic withdrawal,” Dr. Takeuchi and colleagues said. “Our results suggest that discontinuing anticoagulant therapy before polypectomy for subcentimeter polyps may be unnecessary and support the Japanese guidelines, which recommend not withholding anticoagulants for procedures with low bleeding risk.”

The researchers declared CA+CSP to be non-inferior with a 0.4% lower limit of 2-sided 90% CI. “[W]e noted a higher number of total and right-sided polyps in the CA+CSP group, both of which may result in more frequent bleeding episodes, which suggests that CA+CSP may be a relatively safe approach,” the researchers said. “Therefore, we think that CSP may be the least risky polypectomy procedure.”

The mean procedure time per polyp was 59.6 seconds in the CA+CSP group (54.0-65.2 seconds) compared with 94.4 seconds in the HB+HSP group (87.1-101.7 seconds; P less than .001). Mean hospital stay for patients in the CA+CSP group was shorter at 2.9 days (1.8-4.0 days) compared with 5.1 days in the HB+HSP group (4.2-6.1 days; P equals .003).

The study examined patients receiving two different anticoagulant delivery methods and polyp removal procedures, which made it difficult to determine which intervention contributed to the results, the researchers said. In addition, the study was not blinded and polyp type was limited to only subcentimeter polyps.

“Although CA+CSP is considered standard treatment for subcentimeter colorectal polyps in patients receiving anticoagulants, a larger trial is needed to identify a better management strategy for patients receiving DOACs,” the researchers said.

This study was supported by a grant from the Japanese Gastroenterological Association. The authors report no relevant conflicts of interest.

SOURCE: Takeuchi Y et al. Ann Intern Med. 2019;doi: 10.7326/M19-0026 .

The 2019 Acne & Rosacea supplement features a selection of articles on these two topics published in Dermatology News during the previous year, with commentaries by dermatologists Hilary E. Baldwin, MD, and Julie C. Harper, M.D., both past presidents of the American Acne & Rosacea Society. They were also both members of the American Academy of Dermatology work group that developed the AAD’s updated guidelines on the management of acne vulgaris, published in 2016.

Highlights include:

• The global incidence of rosacea
• Rosacea likely undertreated in skin of color
• The impact of isotretinoin on the dermal microbiome
• Laser treatments of acne and rosacea

Click here to view the supplement.

The 2019 Acne & Rosacea supplement features a selection of articles on these two topics published in Dermatology News during the previous year, with commentaries by dermatologists Hilary E. Baldwin, MD, and Julie C. Harper, M.D., both past presidents of the American Acne & Rosacea Society. They were also both members of the American Academy of Dermatology work group that developed the AAD’s updated guidelines on the management of acne vulgaris, published in 2016.

Highlights include:

• The global incidence of rosacea
• Rosacea likely undertreated in skin of color
• The impact of isotretinoin on the dermal microbiome
• Laser treatments of acne and rosacea

Click here to view the supplement.

The 2019 Acne & Rosacea supplement features a selection of articles on these two topics published in Dermatology News during the previous year, with commentaries by dermatologists Hilary E. Baldwin, MD, and Julie C. Harper, M.D., both past presidents of the American Acne & Rosacea Society. They were also both members of the American Academy of Dermatology work group that developed the AAD’s updated guidelines on the management of acne vulgaris, published in 2016.

Highlights include:

• The global incidence of rosacea
• Rosacea likely undertreated in skin of color
• The impact of isotretinoin on the dermal microbiome
• Laser treatments of acne and rosacea

Click here to view the supplement.