ACS Surgery News

An intervention to improve communication and provide more structure to patient "handoffs" among residents dramatically reduced medical errors and preventable adverse events in hospitalized children, according to a report published online Dec. 3 in JAMA.

In a single-center study comparing patient handoffs during the 3-month period before the intervention was implemented against the 3-month period afterward, the rate of medical errors dropped by 46%, from 33.8/100 admissions to 18.3/100. Preventable adverse events similarly decreased, from 3.3/100 admissions to 1.5/100, said Dr. Amy J. Starmer of Boston Children’s Hospital and Harvard Medical School, Boston, and her associates.

"Given the increasing frequency of handoffs in hospitals following resident work-hour reductions and the high frequency with which miscommunications lead to serious medical errors," widespread use of such handoff interventions could have a substantial impact on patient health, they noted.

© danr13/iStockphoto

The investigators performed the before-and-after comparison on two inpatient pediatric units within the same hospital, which included 1,255 children requiring general, subspecialty, and complex-care services during the study period. A total of 42 first-year and third-year residents cared for these patients and participated in the intervention.

Before the intervention, patient handoffs had no standardized structure and involved the use of a printed document that included basic patient information but was not integrated into the electronic health record system.

For the intervention, the residents attended a 2-hour training session in which they discussed best practices for verbal and written handoffs. Handoff procedures were structured to occur on a team basis rather than individually, in a dedicated physical space that was private and quiet, and which were periodically overseen by a chief resident or attending physician.

One of the pediatric units also began using a computerized rather than printed handoff document that was integrated into the electronic health record system and included much more detailed, and regularly updated, patient information.

Overall, 350 medical errors and adverse events were tabulated during the study period, including 77% related to medications, 8.3% related to medical procedures, 4.3% related to diagnostic tests, 3.4% related to other therapies, and 3.7% related to falls.

In particular, the rate of errors that could have had important clinical consequences dropped from 7.3/100 to 3.3/100 admissions, and the rate of errors that could have had such consequences but were prevented decreased from 15/100 to 8.3/100 admissions.

As expected, the rate of nonpreventable errors remained constant (JAMA 2013 Dec. 3 [doi:10.1001/jama.2013.281961]).

Forty of the written handoff documents were reviewed for the presence of 14 important items of patient information. After the intervention, the number of key data omissions was significantly reduced.

"Written handoffs were more comprehensive after the interventions, and verbal handoffs were more likely to occur in a quiet, private location," Dr. Starmer and her associates said.

This study was supported by the Controlled Risk Insurance Company Risk Management Foundation, Boston Children’s Hospital Program for Patient Safety and Quality Research, the Agency for Healthcare Research and Quality, the Child Health Corporation of America, and the National Institutes of Health. No financial conflicts of interest were reported.

An intervention to improve communication and provide more structure to patient "handoffs" among residents dramatically reduced medical errors and preventable adverse events in hospitalized children, according to a report published online Dec. 3 in JAMA.

In a single-center study comparing patient handoffs during the 3-month period before the intervention was implemented against the 3-month period afterward, the rate of medical errors dropped by 46%, from 33.8/100 admissions to 18.3/100. Preventable adverse events similarly decreased, from 3.3/100 admissions to 1.5/100, said Dr. Amy J. Starmer of Boston Children’s Hospital and Harvard Medical School, Boston, and her associates.

"Given the increasing frequency of handoffs in hospitals following resident work-hour reductions and the high frequency with which miscommunications lead to serious medical errors," widespread use of such handoff interventions could have a substantial impact on patient health, they noted.

© danr13/iStockphoto

The investigators performed the before-and-after comparison on two inpatient pediatric units within the same hospital, which included 1,255 children requiring general, subspecialty, and complex-care services during the study period. A total of 42 first-year and third-year residents cared for these patients and participated in the intervention.

Before the intervention, patient handoffs had no standardized structure and involved the use of a printed document that included basic patient information but was not integrated into the electronic health record system.

For the intervention, the residents attended a 2-hour training session in which they discussed best practices for verbal and written handoffs. Handoff procedures were structured to occur on a team basis rather than individually, in a dedicated physical space that was private and quiet, and which were periodically overseen by a chief resident or attending physician.

One of the pediatric units also began using a computerized rather than printed handoff document that was integrated into the electronic health record system and included much more detailed, and regularly updated, patient information.

Overall, 350 medical errors and adverse events were tabulated during the study period, including 77% related to medications, 8.3% related to medical procedures, 4.3% related to diagnostic tests, 3.4% related to other therapies, and 3.7% related to falls.

In particular, the rate of errors that could have had important clinical consequences dropped from 7.3/100 to 3.3/100 admissions, and the rate of errors that could have had such consequences but were prevented decreased from 15/100 to 8.3/100 admissions.

As expected, the rate of nonpreventable errors remained constant (JAMA 2013 Dec. 3 [doi:10.1001/jama.2013.281961]).

Forty of the written handoff documents were reviewed for the presence of 14 important items of patient information. After the intervention, the number of key data omissions was significantly reduced.

"Written handoffs were more comprehensive after the interventions, and verbal handoffs were more likely to occur in a quiet, private location," Dr. Starmer and her associates said.

This study was supported by the Controlled Risk Insurance Company Risk Management Foundation, Boston Children’s Hospital Program for Patient Safety and Quality Research, the Agency for Healthcare Research and Quality, the Child Health Corporation of America, and the National Institutes of Health. No financial conflicts of interest were reported.

An intervention to improve communication and provide more structure to patient "handoffs" among residents dramatically reduced medical errors and preventable adverse events in hospitalized children, according to a report published online Dec. 3 in JAMA.

In a single-center study comparing patient handoffs during the 3-month period before the intervention was implemented against the 3-month period afterward, the rate of medical errors dropped by 46%, from 33.8/100 admissions to 18.3/100. Preventable adverse events similarly decreased, from 3.3/100 admissions to 1.5/100, said Dr. Amy J. Starmer of Boston Children’s Hospital and Harvard Medical School, Boston, and her associates.

"Given the increasing frequency of handoffs in hospitals following resident work-hour reductions and the high frequency with which miscommunications lead to serious medical errors," widespread use of such handoff interventions could have a substantial impact on patient health, they noted.

© danr13/iStockphoto

The investigators performed the before-and-after comparison on two inpatient pediatric units within the same hospital, which included 1,255 children requiring general, subspecialty, and complex-care services during the study period. A total of 42 first-year and third-year residents cared for these patients and participated in the intervention.

Before the intervention, patient handoffs had no standardized structure and involved the use of a printed document that included basic patient information but was not integrated into the electronic health record system.

For the intervention, the residents attended a 2-hour training session in which they discussed best practices for verbal and written handoffs. Handoff procedures were structured to occur on a team basis rather than individually, in a dedicated physical space that was private and quiet, and which were periodically overseen by a chief resident or attending physician.

One of the pediatric units also began using a computerized rather than printed handoff document that was integrated into the electronic health record system and included much more detailed, and regularly updated, patient information.

Overall, 350 medical errors and adverse events were tabulated during the study period, including 77% related to medications, 8.3% related to medical procedures, 4.3% related to diagnostic tests, 3.4% related to other therapies, and 3.7% related to falls.

In particular, the rate of errors that could have had important clinical consequences dropped from 7.3/100 to 3.3/100 admissions, and the rate of errors that could have had such consequences but were prevented decreased from 15/100 to 8.3/100 admissions.

As expected, the rate of nonpreventable errors remained constant (JAMA 2013 Dec. 3 [doi:10.1001/jama.2013.281961]).

Forty of the written handoff documents were reviewed for the presence of 14 important items of patient information. After the intervention, the number of key data omissions was significantly reduced.

"Written handoffs were more comprehensive after the interventions, and verbal handoffs were more likely to occur in a quiet, private location," Dr. Starmer and her associates said.

This study was supported by the Controlled Risk Insurance Company Risk Management Foundation, Boston Children’s Hospital Program for Patient Safety and Quality Research, the Agency for Healthcare Research and Quality, the Child Health Corporation of America, and the National Institutes of Health. No financial conflicts of interest were reported.

Medicaid applications were up more than 15% in October in states that are expanding their Medicaid programs under the Affordable Care Act.

The preliminary data, released by the Health and Human Services department Dec. 3, shows that while Americans have been slow to enroll in private health plans through the online exchanges, many low-income individuals are getting access to insurance coverage through the Medicaid program.

As of October, 23 states and the District of Columbia had expanded their Medicaid programs to include individuals with incomes up to 133% of the federal poverty level. That coverage will begin on Jan. 1, 2014. Two more states – Ohio and Michigan – recently announced plans to expand their programs but have not yet begun enrollment.

During October, the number of applications to Medicaid programs and the Children’s Health Insurance Program (CHIP) were up 15.5% overall in states expanding their eligibility, compared with the average monthly number of applications received from July through September. The figures include both individuals who are newly eligible under the ACA and those who were eligible previously. Comparatively, states that opted not to expand their Medicaid programs saw an increase in applications of 4.1%.

Across all states, more than 2.4 million applications were submitted to state Medicaid and CHIP agencies during October. More than 1.4 million individuals were deemed eligible for the programs.

The figures released by the HHS provide a partial picture of Medicaid enrollment under the ACA. Individuals also are applying to the program through the online insurance exchanges. From Oct. 1 to Nov. 2, 396,261 were determined to be eligible for Medicaid or CHIP after applying for insurance through either a state-based exchange or healthcare.gov, according to the HHS.

[email protected]

On Twitter @MaryEllenNY

Medicaid applications were up more than 15% in October in states that are expanding their Medicaid programs under the Affordable Care Act.

The preliminary data, released by the Health and Human Services department Dec. 3, shows that while Americans have been slow to enroll in private health plans through the online exchanges, many low-income individuals are getting access to insurance coverage through the Medicaid program.

As of October, 23 states and the District of Columbia had expanded their Medicaid programs to include individuals with incomes up to 133% of the federal poverty level. That coverage will begin on Jan. 1, 2014. Two more states – Ohio and Michigan – recently announced plans to expand their programs but have not yet begun enrollment.

During October, the number of applications to Medicaid programs and the Children’s Health Insurance Program (CHIP) were up 15.5% overall in states expanding their eligibility, compared with the average monthly number of applications received from July through September. The figures include both individuals who are newly eligible under the ACA and those who were eligible previously. Comparatively, states that opted not to expand their Medicaid programs saw an increase in applications of 4.1%.

Across all states, more than 2.4 million applications were submitted to state Medicaid and CHIP agencies during October. More than 1.4 million individuals were deemed eligible for the programs.

The figures released by the HHS provide a partial picture of Medicaid enrollment under the ACA. Individuals also are applying to the program through the online insurance exchanges. From Oct. 1 to Nov. 2, 396,261 were determined to be eligible for Medicaid or CHIP after applying for insurance through either a state-based exchange or healthcare.gov, according to the HHS.

[email protected]

On Twitter @MaryEllenNY

Medicaid applications were up more than 15% in October in states that are expanding their Medicaid programs under the Affordable Care Act.

The preliminary data, released by the Health and Human Services department Dec. 3, shows that while Americans have been slow to enroll in private health plans through the online exchanges, many low-income individuals are getting access to insurance coverage through the Medicaid program.

As of October, 23 states and the District of Columbia had expanded their Medicaid programs to include individuals with incomes up to 133% of the federal poverty level. That coverage will begin on Jan. 1, 2014. Two more states – Ohio and Michigan – recently announced plans to expand their programs but have not yet begun enrollment.

During October, the number of applications to Medicaid programs and the Children’s Health Insurance Program (CHIP) were up 15.5% overall in states expanding their eligibility, compared with the average monthly number of applications received from July through September. The figures include both individuals who are newly eligible under the ACA and those who were eligible previously. Comparatively, states that opted not to expand their Medicaid programs saw an increase in applications of 4.1%.

Across all states, more than 2.4 million applications were submitted to state Medicaid and CHIP agencies during October. More than 1.4 million individuals were deemed eligible for the programs.

The figures released by the HHS provide a partial picture of Medicaid enrollment under the ACA. Individuals also are applying to the program through the online insurance exchanges. From Oct. 1 to Nov. 2, 396,261 were determined to be eligible for Medicaid or CHIP after applying for insurance through either a state-based exchange or healthcare.gov, according to the HHS.

[email protected]

On Twitter @MaryEllenNY

Visitors to healthcare.gov now can view physician networks, deductibles, copayments, and formularies as "window shoppers" before they sign up for a health insurance plan – information that both doctors and patients have been seeking.

The new functionality was announced Dec. 2 by the Centers for Medicare and Medicaid Services.

At a Nov. 26 White House meeting on Affordable Care Act concerns, representatives of several physician organizations voiced concern that patients could not see whether their physician or preferred hospital was in a plan’s network during the shopping process, according to Bob Doherty, senior vice president for governmental affairs and public policy for the American College of Physicians.

Mr. Doherty, who attended the White House meeting, said that physician groups also told administration officials that patients and physicians needed information on formularies. Pharmaceuticals – at least one medication from each therapeutic class – must be covered by health exchange plans as an essential health benefit.

"But that doesn’t mean necessarily that your own particular drugs are on that plan’s formulary," Mr. Doherty said. The physician groups argued that more transparency was needed.

The same is true for provider networks. "From a consumer point of view, you may decide that if you can get a plan with lower premium and a deductible you can afford, you may choose to forgo your doctor or hospital," Mr. Doherty said. "That’s okay as long as you make an informed choice," he said, adding that without the ability to see networks, it was impossible to make such a choice.

Now, the networks are visible, but the question is whether the lists are up-to-date, he said. Physician groups also want "more transparency from the insurance industry, disclosing decisions on why they include or don’t include doctors in their networks and why they delist" physicians, Mr. Doherty said.

Physicians are getting help from Rep. Darrell Issa (R-Calif.), chairman of the House Oversight and Government Reform Committee. Rep. Issa sent a letter to 15 insurance companies on Nov. 29, asking for documents "related to the reevaluation of provider networks and payment rates, as well as communications with the administration about potential changes to health plans limiting or changing health care access," according to a statement.

"Even among the individuals fortunate enough to keep their plans, many Americans are finding that access to their preferred doctor(s) is being abruptly terminated," wrote Rep. Issa, adding, "Some health insurers have acknowledged that they are slashing provider payment rates for plans offered on Obamacare exchanges."

The letter requested a response from the insurers by Dec. 13.

[email protected]

On Twitter @aliciaault

Visitors to healthcare.gov now can view physician networks, deductibles, copayments, and formularies as "window shoppers" before they sign up for a health insurance plan – information that both doctors and patients have been seeking.

The new functionality was announced Dec. 2 by the Centers for Medicare and Medicaid Services.

At a Nov. 26 White House meeting on Affordable Care Act concerns, representatives of several physician organizations voiced concern that patients could not see whether their physician or preferred hospital was in a plan’s network during the shopping process, according to Bob Doherty, senior vice president for governmental affairs and public policy for the American College of Physicians.

Mr. Doherty, who attended the White House meeting, said that physician groups also told administration officials that patients and physicians needed information on formularies. Pharmaceuticals – at least one medication from each therapeutic class – must be covered by health exchange plans as an essential health benefit.

"But that doesn’t mean necessarily that your own particular drugs are on that plan’s formulary," Mr. Doherty said. The physician groups argued that more transparency was needed.

The same is true for provider networks. "From a consumer point of view, you may decide that if you can get a plan with lower premium and a deductible you can afford, you may choose to forgo your doctor or hospital," Mr. Doherty said. "That’s okay as long as you make an informed choice," he said, adding that without the ability to see networks, it was impossible to make such a choice.

Now, the networks are visible, but the question is whether the lists are up-to-date, he said. Physician groups also want "more transparency from the insurance industry, disclosing decisions on why they include or don’t include doctors in their networks and why they delist" physicians, Mr. Doherty said.

Physicians are getting help from Rep. Darrell Issa (R-Calif.), chairman of the House Oversight and Government Reform Committee. Rep. Issa sent a letter to 15 insurance companies on Nov. 29, asking for documents "related to the reevaluation of provider networks and payment rates, as well as communications with the administration about potential changes to health plans limiting or changing health care access," according to a statement.

"Even among the individuals fortunate enough to keep their plans, many Americans are finding that access to their preferred doctor(s) is being abruptly terminated," wrote Rep. Issa, adding, "Some health insurers have acknowledged that they are slashing provider payment rates for plans offered on Obamacare exchanges."

The letter requested a response from the insurers by Dec. 13.

[email protected]

On Twitter @aliciaault

Visitors to healthcare.gov now can view physician networks, deductibles, copayments, and formularies as "window shoppers" before they sign up for a health insurance plan – information that both doctors and patients have been seeking.

The new functionality was announced Dec. 2 by the Centers for Medicare and Medicaid Services.

At a Nov. 26 White House meeting on Affordable Care Act concerns, representatives of several physician organizations voiced concern that patients could not see whether their physician or preferred hospital was in a plan’s network during the shopping process, according to Bob Doherty, senior vice president for governmental affairs and public policy for the American College of Physicians.

Mr. Doherty, who attended the White House meeting, said that physician groups also told administration officials that patients and physicians needed information on formularies. Pharmaceuticals – at least one medication from each therapeutic class – must be covered by health exchange plans as an essential health benefit.

"But that doesn’t mean necessarily that your own particular drugs are on that plan’s formulary," Mr. Doherty said. The physician groups argued that more transparency was needed.

The same is true for provider networks. "From a consumer point of view, you may decide that if you can get a plan with lower premium and a deductible you can afford, you may choose to forgo your doctor or hospital," Mr. Doherty said. "That’s okay as long as you make an informed choice," he said, adding that without the ability to see networks, it was impossible to make such a choice.

Now, the networks are visible, but the question is whether the lists are up-to-date, he said. Physician groups also want "more transparency from the insurance industry, disclosing decisions on why they include or don’t include doctors in their networks and why they delist" physicians, Mr. Doherty said.

Physicians are getting help from Rep. Darrell Issa (R-Calif.), chairman of the House Oversight and Government Reform Committee. Rep. Issa sent a letter to 15 insurance companies on Nov. 29, asking for documents "related to the reevaluation of provider networks and payment rates, as well as communications with the administration about potential changes to health plans limiting or changing health care access," according to a statement.

"Even among the individuals fortunate enough to keep their plans, many Americans are finding that access to their preferred doctor(s) is being abruptly terminated," wrote Rep. Issa, adding, "Some health insurers have acknowledged that they are slashing provider payment rates for plans offered on Obamacare exchanges."

The letter requested a response from the insurers by Dec. 13.

[email protected]

On Twitter @aliciaault

MELBOURNE – Gastric banding can achieve significant weight loss and remission of diabetes in patients with type 2 diabetes who are overweight but not obese, suggesting that a lower body mass index threshold could be considered for the procedure, according to results from a randomized controlled trial.

Type 2 diabetes patients with a BMI of 25-30 kg/m² who received a laparoscopic gastric band achieved significantly greater weight loss (11 kg vs. 1 kg) and significantly higher rates of diabetes remission (52% vs. 8%) than did those who were treated with standard medical care.

According to an oral presentation at the International Diabetes Federation world congress, patients treated with gastric banding also required much less medication to achieve reductions in hemoglobin A_1c.

"In the surgical group, we had a large number continuing metformin but basically very few taking other therapies, and the four people taking insulin all came off insulin by 2 years, whereas in the medical arm we had intensification of sulfonylurea, exenatide, insulin, and even gliptin therapy," said Dr. John Wentworth, an endocrinologist and research fellow at the Monash University Centre for Obesity Research and Education, Melbourne.

The study also found significant improvements in physical quality of life measures among the gastric banding group compared with the medical care group.

"Part of it was that people lost weight and they were pleased about it, but I think the other part was that they used less medication," Dr. Wentworth said in an interview.

Researchers also observed a small improvement in diastolic blood pressure, as well as significant improvements in insulin resistance and HDL levels, among patients treated with gastric banding.

The 2-year Australian study enrolled 51 overweight type 2 diabetes patients with relatively short disease duration (less than 5 years) and without underlying pancreatic pathology. Patients were randomized to either laparoscopic gastric banding or standard medical care involving regular consultations with a dietician, diabetes educator, and physician.

The study’s primary outcome was remission of diabetes at 2 years, which was defined as fasting and 2-hour glucose measurements of less than 7.0 mmol/L and less than 11.1 mmol/L, respectively, following an oral glucose challenge after at least 48 hours off medication.

Dr. Wentworth said gastric banding was a reasonable option in terms of achieving weight loss and improving glycemic outcomes with a much lower medication burden.

"Traditionally, bariatric surgery was a quite high risk procedure, looking back two or more decades, and you only targeted it to people who had very serious obesity and who had clear problems with it," Dr. Wentworth said.

"Things have become a lot safer in all types of bariatric surgery, so it becomes more of an option to offer people."

However, he stressed that the study population was carefully selected to include only people with shorter disease duration, and that gastric banding was not likely to achieve remission in patients with very long-standing and poorly controlled disease.

There were some complications in the surgical group, with one revision operation, and five episodes of esophageal obstruction in three patients, which required removal of fluid from the band.

A member of the audience pointed out that the medical care group might have achieved better results with greater use of glucagonlike peptide–1 (GLP-1) agonists, which can also have an effect on obesity. Dr. Wentworth said there was some use of the GLP-1 agonist exenatide, but it was not offered routinely to patients, and he acknowledged that this may have affected outcomes.

The Centre for Obesity Research and Education has received educational funding from Allergan, but there were no other financial conflicts of interest declared.

MELBOURNE – Gastric banding can achieve significant weight loss and remission of diabetes in patients with type 2 diabetes who are overweight but not obese, suggesting that a lower body mass index threshold could be considered for the procedure, according to results from a randomized controlled trial.

Type 2 diabetes patients with a BMI of 25-30 kg/m² who received a laparoscopic gastric band achieved significantly greater weight loss (11 kg vs. 1 kg) and significantly higher rates of diabetes remission (52% vs. 8%) than did those who were treated with standard medical care.

According to an oral presentation at the International Diabetes Federation world congress, patients treated with gastric banding also required much less medication to achieve reductions in hemoglobin A_1c.

"In the surgical group, we had a large number continuing metformin but basically very few taking other therapies, and the four people taking insulin all came off insulin by 2 years, whereas in the medical arm we had intensification of sulfonylurea, exenatide, insulin, and even gliptin therapy," said Dr. John Wentworth, an endocrinologist and research fellow at the Monash University Centre for Obesity Research and Education, Melbourne.

The study also found significant improvements in physical quality of life measures among the gastric banding group compared with the medical care group.

"Part of it was that people lost weight and they were pleased about it, but I think the other part was that they used less medication," Dr. Wentworth said in an interview.

Researchers also observed a small improvement in diastolic blood pressure, as well as significant improvements in insulin resistance and HDL levels, among patients treated with gastric banding.

The 2-year Australian study enrolled 51 overweight type 2 diabetes patients with relatively short disease duration (less than 5 years) and without underlying pancreatic pathology. Patients were randomized to either laparoscopic gastric banding or standard medical care involving regular consultations with a dietician, diabetes educator, and physician.

The study’s primary outcome was remission of diabetes at 2 years, which was defined as fasting and 2-hour glucose measurements of less than 7.0 mmol/L and less than 11.1 mmol/L, respectively, following an oral glucose challenge after at least 48 hours off medication.

Dr. Wentworth said gastric banding was a reasonable option in terms of achieving weight loss and improving glycemic outcomes with a much lower medication burden.

"Traditionally, bariatric surgery was a quite high risk procedure, looking back two or more decades, and you only targeted it to people who had very serious obesity and who had clear problems with it," Dr. Wentworth said.

"Things have become a lot safer in all types of bariatric surgery, so it becomes more of an option to offer people."

However, he stressed that the study population was carefully selected to include only people with shorter disease duration, and that gastric banding was not likely to achieve remission in patients with very long-standing and poorly controlled disease.

There were some complications in the surgical group, with one revision operation, and five episodes of esophageal obstruction in three patients, which required removal of fluid from the band.

A member of the audience pointed out that the medical care group might have achieved better results with greater use of glucagonlike peptide–1 (GLP-1) agonists, which can also have an effect on obesity. Dr. Wentworth said there was some use of the GLP-1 agonist exenatide, but it was not offered routinely to patients, and he acknowledged that this may have affected outcomes.

The Centre for Obesity Research and Education has received educational funding from Allergan, but there were no other financial conflicts of interest declared.

MELBOURNE – Gastric banding can achieve significant weight loss and remission of diabetes in patients with type 2 diabetes who are overweight but not obese, suggesting that a lower body mass index threshold could be considered for the procedure, according to results from a randomized controlled trial.

Type 2 diabetes patients with a BMI of 25-30 kg/m² who received a laparoscopic gastric band achieved significantly greater weight loss (11 kg vs. 1 kg) and significantly higher rates of diabetes remission (52% vs. 8%) than did those who were treated with standard medical care.

According to an oral presentation at the International Diabetes Federation world congress, patients treated with gastric banding also required much less medication to achieve reductions in hemoglobin A_1c.

"In the surgical group, we had a large number continuing metformin but basically very few taking other therapies, and the four people taking insulin all came off insulin by 2 years, whereas in the medical arm we had intensification of sulfonylurea, exenatide, insulin, and even gliptin therapy," said Dr. John Wentworth, an endocrinologist and research fellow at the Monash University Centre for Obesity Research and Education, Melbourne.

The study also found significant improvements in physical quality of life measures among the gastric banding group compared with the medical care group.

"Part of it was that people lost weight and they were pleased about it, but I think the other part was that they used less medication," Dr. Wentworth said in an interview.

Researchers also observed a small improvement in diastolic blood pressure, as well as significant improvements in insulin resistance and HDL levels, among patients treated with gastric banding.

The 2-year Australian study enrolled 51 overweight type 2 diabetes patients with relatively short disease duration (less than 5 years) and without underlying pancreatic pathology. Patients were randomized to either laparoscopic gastric banding or standard medical care involving regular consultations with a dietician, diabetes educator, and physician.

The study’s primary outcome was remission of diabetes at 2 years, which was defined as fasting and 2-hour glucose measurements of less than 7.0 mmol/L and less than 11.1 mmol/L, respectively, following an oral glucose challenge after at least 48 hours off medication.

Dr. Wentworth said gastric banding was a reasonable option in terms of achieving weight loss and improving glycemic outcomes with a much lower medication burden.

"Traditionally, bariatric surgery was a quite high risk procedure, looking back two or more decades, and you only targeted it to people who had very serious obesity and who had clear problems with it," Dr. Wentworth said.

"Things have become a lot safer in all types of bariatric surgery, so it becomes more of an option to offer people."

However, he stressed that the study population was carefully selected to include only people with shorter disease duration, and that gastric banding was not likely to achieve remission in patients with very long-standing and poorly controlled disease.

There were some complications in the surgical group, with one revision operation, and five episodes of esophageal obstruction in three patients, which required removal of fluid from the band.

A member of the audience pointed out that the medical care group might have achieved better results with greater use of glucagonlike peptide–1 (GLP-1) agonists, which can also have an effect on obesity. Dr. Wentworth said there was some use of the GLP-1 agonist exenatide, but it was not offered routinely to patients, and he acknowledged that this may have affected outcomes.

The Centre for Obesity Research and Education has received educational funding from Allergan, but there were no other financial conflicts of interest declared.

NATIONAL HARBOR, MD. – Pregnancy occurred in more than half of infertile women who had a segmental laparoscopic bowel resection for endometriosis.

Of 155 women, 96 (62%) conceived after the surgery. Most of these pregnancies (71 of 96; 74%) were spontaneous, Dr. Rosa Maria Neme reported at a meeting sponsored by AAGL.

The prospective study included women treated during 2009-2012 at the University of São Paulo, Brazil, said Dr. Neme, director of the university’s endometriosis center. The patients were a mean of 32 years old.

Most (92%) had bowel symptoms, including pain during defecation, diarrhea and constipation, abdominal bloating, and dyschezia. Endometriosis-related symptoms were present in all, and included dysmenorrhea, nonmenstrual pelvic pain and dyspareunia, tenesmus, cyclic rectal bleeding, lower back pain, and asthenia.

An associated infertility was present in 62% (155), with a mean duration of 18 months. Most patients (78%) had already undergone some form of fertility treatment before surgery and 69% had undergone a previous surgery for pelvic pain.

All of the patients had a torus bowel resection. A number of other procedures also were performed during the surgery, including extensive ureterolysis (80%), ovarian cystectomy (70%), partial vaginal resection (20%), and appendectomy (20%).

The mean operative time was 117 minutes. There were no conversions to open surgery, no transfusions, and no intra- or postoperative complications. The mean length of stay was 3 days. The pathology of all resected lesions was stromal and glandular endometriosis.

After the surgery, 96 pregnancies occurred among the subgroup with infertility (62%). The median time to conception was 8 months. The majority of pregnancies were spontaneous (71), with the rest achieved by in vitro fertilization. There were four miscarriages.

A quality of life survey was conducted at 6 months. By that time, dysmenorrhea, dyspareunia and pain on defecation, intestinal cramping, diarrhea and constipation had disappeared in all women.

Dr. Neme had no financial disclosures.

[email protected]

NATIONAL HARBOR, MD. – Pregnancy occurred in more than half of infertile women who had a segmental laparoscopic bowel resection for endometriosis.

Of 155 women, 96 (62%) conceived after the surgery. Most of these pregnancies (71 of 96; 74%) were spontaneous, Dr. Rosa Maria Neme reported at a meeting sponsored by AAGL.

The prospective study included women treated during 2009-2012 at the University of São Paulo, Brazil, said Dr. Neme, director of the university’s endometriosis center. The patients were a mean of 32 years old.

Most (92%) had bowel symptoms, including pain during defecation, diarrhea and constipation, abdominal bloating, and dyschezia. Endometriosis-related symptoms were present in all, and included dysmenorrhea, nonmenstrual pelvic pain and dyspareunia, tenesmus, cyclic rectal bleeding, lower back pain, and asthenia.

An associated infertility was present in 62% (155), with a mean duration of 18 months. Most patients (78%) had already undergone some form of fertility treatment before surgery and 69% had undergone a previous surgery for pelvic pain.

All of the patients had a torus bowel resection. A number of other procedures also were performed during the surgery, including extensive ureterolysis (80%), ovarian cystectomy (70%), partial vaginal resection (20%), and appendectomy (20%).

The mean operative time was 117 minutes. There were no conversions to open surgery, no transfusions, and no intra- or postoperative complications. The mean length of stay was 3 days. The pathology of all resected lesions was stromal and glandular endometriosis.

After the surgery, 96 pregnancies occurred among the subgroup with infertility (62%). The median time to conception was 8 months. The majority of pregnancies were spontaneous (71), with the rest achieved by in vitro fertilization. There were four miscarriages.

A quality of life survey was conducted at 6 months. By that time, dysmenorrhea, dyspareunia and pain on defecation, intestinal cramping, diarrhea and constipation had disappeared in all women.

Dr. Neme had no financial disclosures.

[email protected]

NATIONAL HARBOR, MD. – Pregnancy occurred in more than half of infertile women who had a segmental laparoscopic bowel resection for endometriosis.

Of 155 women, 96 (62%) conceived after the surgery. Most of these pregnancies (71 of 96; 74%) were spontaneous, Dr. Rosa Maria Neme reported at a meeting sponsored by AAGL.

The prospective study included women treated during 2009-2012 at the University of São Paulo, Brazil, said Dr. Neme, director of the university’s endometriosis center. The patients were a mean of 32 years old.

Most (92%) had bowel symptoms, including pain during defecation, diarrhea and constipation, abdominal bloating, and dyschezia. Endometriosis-related symptoms were present in all, and included dysmenorrhea, nonmenstrual pelvic pain and dyspareunia, tenesmus, cyclic rectal bleeding, lower back pain, and asthenia.

An associated infertility was present in 62% (155), with a mean duration of 18 months. Most patients (78%) had already undergone some form of fertility treatment before surgery and 69% had undergone a previous surgery for pelvic pain.

All of the patients had a torus bowel resection. A number of other procedures also were performed during the surgery, including extensive ureterolysis (80%), ovarian cystectomy (70%), partial vaginal resection (20%), and appendectomy (20%).

The mean operative time was 117 minutes. There were no conversions to open surgery, no transfusions, and no intra- or postoperative complications. The mean length of stay was 3 days. The pathology of all resected lesions was stromal and glandular endometriosis.

After the surgery, 96 pregnancies occurred among the subgroup with infertility (62%). The median time to conception was 8 months. The majority of pregnancies were spontaneous (71), with the rest achieved by in vitro fertilization. There were four miscarriages.

A quality of life survey was conducted at 6 months. By that time, dysmenorrhea, dyspareunia and pain on defecation, intestinal cramping, diarrhea and constipation had disappeared in all women.

Dr. Neme had no financial disclosures.

[email protected]

ATLANTA – Higher baseline levels of cognitive impairment are associated with poorer weight loss outcomes after bariatric surgery.

"People with problems of memory, problem solving, or attention prior to surgery show reduced ability to lose weight," said John Gunstad, Ph.D., at Obesity Week, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

In a prospective study of 109 bariatric surgery patients enrolled in the LABS (Longitudinal Assessment of Bariatric Surgery) study and 41 obese matched controls who’d not had surgery, Dr. Gunstad, who is professor and chairman of neuroscience at Kent (Ohio) State University, and his colleagues assessed all participants’ cognitive function at baseline, at 12 weeks, and at 12, 24, and 36 months.

They found that 25% of all surgical patients had baseline cognitive impairment. "These were individuals who were at least 1.5 standard deviations below normal-weight persons in at least one cognitive domain," said Dr. Gunstad. "If these individuals came to my clinic, I would have to diagnose them with some kind of cognitive disorder."

Expanding the criteria to 1 standard deviation meant that 40% of participants had subtle impairment. "Patients who are coming in for bariatric surgery are between 5 and 8 times more likely to have cognitive impairment than their normal-weight counterparts. That’s a remarkable number," said Dr. Gunstad.

At 12 weeks, surgery patients who’d lost an average of 48 pounds showed gains in cognitive functioning. Overall, the study showed initial, rapid cognitive improvement, and then either continued or sustained improvement 3 years out.

"We went from a quarter of patients being clinically impaired prior to surgery," said Dr. Gunstad. "At 3 years after surgery, that number was down to 4%."

However, in a related study, Dr. Gunstad and his colleagues found that greater levels of cognitive impairment correlated to less weight loss at all follow-up points (Surg. Obes. Relat. Dis. 2013;9:765-70).

Dr. Gunstad said this was likely due to patient adherence issues after the tumult of bariatric surgery. "You have to eat in a different way. You have to think in a different way. You have to restructure every moment of your life," said Dr. Gunstad. "If you have problems with memory, problem solving, or organizing, it will be much more difficult to make and persist with those changes."

The clinical implication, said Dr. Gunstad, is that better screening of bariatric surgery candidates might be helpful. "If we know the cognitive status of our patients, it’s likely we will know what the outcomes will be," he said.

The drawback, he said, is that even though most third-party payers will cover the costs of evaluations, if a physician has a large practice of hundreds of patients, then the number of referrals might be overwhelming to the system, which might not have enough neuropsychologists to perform the tests.

Self-reporting might also be an issue because of the phenomenon of the "worried well" – the patients who overreport their problems – or because the patients with cognitive impairment won’t necessarily recognize the symptoms they need to report, said Dr. Gunstad.

By next year, said Dr. Gunstad, he hoped he and his colleagues will have finalized a better screening tool for clinicians who treat bariatric surgery patients.

Dr. Gunstad did not report any financial disclosures.

[email protected]

ATLANTA – Higher baseline levels of cognitive impairment are associated with poorer weight loss outcomes after bariatric surgery.

"People with problems of memory, problem solving, or attention prior to surgery show reduced ability to lose weight," said John Gunstad, Ph.D., at Obesity Week, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

In a prospective study of 109 bariatric surgery patients enrolled in the LABS (Longitudinal Assessment of Bariatric Surgery) study and 41 obese matched controls who’d not had surgery, Dr. Gunstad, who is professor and chairman of neuroscience at Kent (Ohio) State University, and his colleagues assessed all participants’ cognitive function at baseline, at 12 weeks, and at 12, 24, and 36 months.

They found that 25% of all surgical patients had baseline cognitive impairment. "These were individuals who were at least 1.5 standard deviations below normal-weight persons in at least one cognitive domain," said Dr. Gunstad. "If these individuals came to my clinic, I would have to diagnose them with some kind of cognitive disorder."

Expanding the criteria to 1 standard deviation meant that 40% of participants had subtle impairment. "Patients who are coming in for bariatric surgery are between 5 and 8 times more likely to have cognitive impairment than their normal-weight counterparts. That’s a remarkable number," said Dr. Gunstad.

At 12 weeks, surgery patients who’d lost an average of 48 pounds showed gains in cognitive functioning. Overall, the study showed initial, rapid cognitive improvement, and then either continued or sustained improvement 3 years out.

"We went from a quarter of patients being clinically impaired prior to surgery," said Dr. Gunstad. "At 3 years after surgery, that number was down to 4%."

However, in a related study, Dr. Gunstad and his colleagues found that greater levels of cognitive impairment correlated to less weight loss at all follow-up points (Surg. Obes. Relat. Dis. 2013;9:765-70).

Dr. Gunstad said this was likely due to patient adherence issues after the tumult of bariatric surgery. "You have to eat in a different way. You have to think in a different way. You have to restructure every moment of your life," said Dr. Gunstad. "If you have problems with memory, problem solving, or organizing, it will be much more difficult to make and persist with those changes."

The clinical implication, said Dr. Gunstad, is that better screening of bariatric surgery candidates might be helpful. "If we know the cognitive status of our patients, it’s likely we will know what the outcomes will be," he said.

The drawback, he said, is that even though most third-party payers will cover the costs of evaluations, if a physician has a large practice of hundreds of patients, then the number of referrals might be overwhelming to the system, which might not have enough neuropsychologists to perform the tests.

Self-reporting might also be an issue because of the phenomenon of the "worried well" – the patients who overreport their problems – or because the patients with cognitive impairment won’t necessarily recognize the symptoms they need to report, said Dr. Gunstad.

By next year, said Dr. Gunstad, he hoped he and his colleagues will have finalized a better screening tool for clinicians who treat bariatric surgery patients.

Dr. Gunstad did not report any financial disclosures.

[email protected]

ATLANTA – Higher baseline levels of cognitive impairment are associated with poorer weight loss outcomes after bariatric surgery.

"People with problems of memory, problem solving, or attention prior to surgery show reduced ability to lose weight," said John Gunstad, Ph.D., at Obesity Week, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

In a prospective study of 109 bariatric surgery patients enrolled in the LABS (Longitudinal Assessment of Bariatric Surgery) study and 41 obese matched controls who’d not had surgery, Dr. Gunstad, who is professor and chairman of neuroscience at Kent (Ohio) State University, and his colleagues assessed all participants’ cognitive function at baseline, at 12 weeks, and at 12, 24, and 36 months.

They found that 25% of all surgical patients had baseline cognitive impairment. "These were individuals who were at least 1.5 standard deviations below normal-weight persons in at least one cognitive domain," said Dr. Gunstad. "If these individuals came to my clinic, I would have to diagnose them with some kind of cognitive disorder."

Expanding the criteria to 1 standard deviation meant that 40% of participants had subtle impairment. "Patients who are coming in for bariatric surgery are between 5 and 8 times more likely to have cognitive impairment than their normal-weight counterparts. That’s a remarkable number," said Dr. Gunstad.

At 12 weeks, surgery patients who’d lost an average of 48 pounds showed gains in cognitive functioning. Overall, the study showed initial, rapid cognitive improvement, and then either continued or sustained improvement 3 years out.

"We went from a quarter of patients being clinically impaired prior to surgery," said Dr. Gunstad. "At 3 years after surgery, that number was down to 4%."

However, in a related study, Dr. Gunstad and his colleagues found that greater levels of cognitive impairment correlated to less weight loss at all follow-up points (Surg. Obes. Relat. Dis. 2013;9:765-70).

Dr. Gunstad said this was likely due to patient adherence issues after the tumult of bariatric surgery. "You have to eat in a different way. You have to think in a different way. You have to restructure every moment of your life," said Dr. Gunstad. "If you have problems with memory, problem solving, or organizing, it will be much more difficult to make and persist with those changes."

The clinical implication, said Dr. Gunstad, is that better screening of bariatric surgery candidates might be helpful. "If we know the cognitive status of our patients, it’s likely we will know what the outcomes will be," he said.

The drawback, he said, is that even though most third-party payers will cover the costs of evaluations, if a physician has a large practice of hundreds of patients, then the number of referrals might be overwhelming to the system, which might not have enough neuropsychologists to perform the tests.

Self-reporting might also be an issue because of the phenomenon of the "worried well" – the patients who overreport their problems – or because the patients with cognitive impairment won’t necessarily recognize the symptoms they need to report, said Dr. Gunstad.

By next year, said Dr. Gunstad, he hoped he and his colleagues will have finalized a better screening tool for clinicians who treat bariatric surgery patients.

Dr. Gunstad did not report any financial disclosures.

[email protected]

Payments for outpatient services and those provided at ambulatory surgical centers will be bundled in the same way as inpatient procedures, with exceptions for some cardiology-related services, under the final rule for Medicare’s 2014 Hospital Outpatient Prospective Payment System.

Further, five levels of outpatient codes for both new and established patients will be replaced with a single code for all visits, according to the final rule.

Having a single code and a single payment "is more administratively simple for hospitals and better reflects hospital resources involved in supporting an outpatient visit," according to a statement from the Centers for Medicare and Medicaid Services.

Under the final rule, supporting items and services associated with a procedure are bundled into a single payment, including drugs, biologicals, and radiopharmaceuticals that function as supplies when used in a diagnostic test or procedure; drugs and biologicals that function as supplies when used in a surgical procedure, including skin substitutes; certain clinical diagnostic laboratory services; certain procedures that are never done without a primary procedure, and device removal procedures.

The bundling of these services and supplies will create efficiencies and lower costs, CMS Principal Deputy Administrator Jon Blum, said in a statement. The final rule "gives hospitals a stake in managing their resources to generate better coordinated and, ultimately, more affordable outpatient care," he added.

Officials at the American College of Cardiology said they were pleased to see that the CMS did not bundle imaging services such as echocardiography, as had been initially proposed. The organization says this is because of "significant lobbying work" by the ACC and the American Society of Echocardiography.

Cardiologists also got a reprieve when the agency delayed until 2015 bundled payment for percutaneous coronary interventions and placement of implantable cardioverter defibrillators.

The final rule was not so favorable for oncologists. The rule continues the practice of paying average sales price plus 6% for drugs and biologics that are administered on an outpatient basis. When the effects of federal budget sequestration are factored in, that pay rate drops by 2%, which means that oncologists are often barely able to cover the cost of a drug, according to an American Society of Clinical Oncology policy expert who spoke on background.

The final rule also requires outpatient departments to collect data on several new performance measures, including influenza vaccination among health care personnel, appropriate follow-up intervals for normal colonoscopy in average-risk patients, avoidance of inappropriate use of colonoscopy follow-up in patients with a history of polyps, and improvement in visual function within 90 days of cataract surgery.

Ambulatory surgical centers (ASCs)will have to collect data on the two colonoscopy measures and the cataract measure. The data will be used to set payments in 2016.

The CMS removed the requirement that hospitals document referrals from the outpatient setting to cardiac rehabilitation, saying that it was too burdensome.

The final rule also established the performance period (all of 2014) and baseline period (all of 2012) for measuring catheter-associated urinary tract infection, central line-associated bloodstream infection, and surgical site infection measures for the Hospital Value-Based Purchasing Program in 2016.

The final Hospital Outpatient Prospective Payment System (OPPS) rule applies to more than 4,000 hospitals, including general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children’s hospitals, and cancer hospitals, and also 5,000 Medicare-participating ASCs. The OPPS covers most outpatient services, and partial hospitalization at outpatient departments and community mental health centers. The CMS estimates that in 2014, the agency will pay $50 billion for outpatient procedures and about $4 billion for ASC procedures.

The rule is open for comment at www.regulations.gov until Jan. 27, 2014.

[email protected]

On Twitter @aliciaault

Payments for outpatient services and those provided at ambulatory surgical centers will be bundled in the same way as inpatient procedures, with exceptions for some cardiology-related services, under the final rule for Medicare’s 2014 Hospital Outpatient Prospective Payment System.

Further, five levels of outpatient codes for both new and established patients will be replaced with a single code for all visits, according to the final rule.

Having a single code and a single payment "is more administratively simple for hospitals and better reflects hospital resources involved in supporting an outpatient visit," according to a statement from the Centers for Medicare and Medicaid Services.

Under the final rule, supporting items and services associated with a procedure are bundled into a single payment, including drugs, biologicals, and radiopharmaceuticals that function as supplies when used in a diagnostic test or procedure; drugs and biologicals that function as supplies when used in a surgical procedure, including skin substitutes; certain clinical diagnostic laboratory services; certain procedures that are never done without a primary procedure, and device removal procedures.

The bundling of these services and supplies will create efficiencies and lower costs, CMS Principal Deputy Administrator Jon Blum, said in a statement. The final rule "gives hospitals a stake in managing their resources to generate better coordinated and, ultimately, more affordable outpatient care," he added.

Officials at the American College of Cardiology said they were pleased to see that the CMS did not bundle imaging services such as echocardiography, as had been initially proposed. The organization says this is because of "significant lobbying work" by the ACC and the American Society of Echocardiography.

Cardiologists also got a reprieve when the agency delayed until 2015 bundled payment for percutaneous coronary interventions and placement of implantable cardioverter defibrillators.

The final rule was not so favorable for oncologists. The rule continues the practice of paying average sales price plus 6% for drugs and biologics that are administered on an outpatient basis. When the effects of federal budget sequestration are factored in, that pay rate drops by 2%, which means that oncologists are often barely able to cover the cost of a drug, according to an American Society of Clinical Oncology policy expert who spoke on background.

The final rule also requires outpatient departments to collect data on several new performance measures, including influenza vaccination among health care personnel, appropriate follow-up intervals for normal colonoscopy in average-risk patients, avoidance of inappropriate use of colonoscopy follow-up in patients with a history of polyps, and improvement in visual function within 90 days of cataract surgery.

Ambulatory surgical centers (ASCs)will have to collect data on the two colonoscopy measures and the cataract measure. The data will be used to set payments in 2016.

The CMS removed the requirement that hospitals document referrals from the outpatient setting to cardiac rehabilitation, saying that it was too burdensome.

The final rule also established the performance period (all of 2014) and baseline period (all of 2012) for measuring catheter-associated urinary tract infection, central line-associated bloodstream infection, and surgical site infection measures for the Hospital Value-Based Purchasing Program in 2016.

The final Hospital Outpatient Prospective Payment System (OPPS) rule applies to more than 4,000 hospitals, including general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children’s hospitals, and cancer hospitals, and also 5,000 Medicare-participating ASCs. The OPPS covers most outpatient services, and partial hospitalization at outpatient departments and community mental health centers. The CMS estimates that in 2014, the agency will pay $50 billion for outpatient procedures and about $4 billion for ASC procedures.

The rule is open for comment at www.regulations.gov until Jan. 27, 2014.

[email protected]

On Twitter @aliciaault

Payments for outpatient services and those provided at ambulatory surgical centers will be bundled in the same way as inpatient procedures, with exceptions for some cardiology-related services, under the final rule for Medicare’s 2014 Hospital Outpatient Prospective Payment System.

Further, five levels of outpatient codes for both new and established patients will be replaced with a single code for all visits, according to the final rule.

Having a single code and a single payment "is more administratively simple for hospitals and better reflects hospital resources involved in supporting an outpatient visit," according to a statement from the Centers for Medicare and Medicaid Services.

Under the final rule, supporting items and services associated with a procedure are bundled into a single payment, including drugs, biologicals, and radiopharmaceuticals that function as supplies when used in a diagnostic test or procedure; drugs and biologicals that function as supplies when used in a surgical procedure, including skin substitutes; certain clinical diagnostic laboratory services; certain procedures that are never done without a primary procedure, and device removal procedures.

The bundling of these services and supplies will create efficiencies and lower costs, CMS Principal Deputy Administrator Jon Blum, said in a statement. The final rule "gives hospitals a stake in managing their resources to generate better coordinated and, ultimately, more affordable outpatient care," he added.

Officials at the American College of Cardiology said they were pleased to see that the CMS did not bundle imaging services such as echocardiography, as had been initially proposed. The organization says this is because of "significant lobbying work" by the ACC and the American Society of Echocardiography.

Cardiologists also got a reprieve when the agency delayed until 2015 bundled payment for percutaneous coronary interventions and placement of implantable cardioverter defibrillators.

The final rule was not so favorable for oncologists. The rule continues the practice of paying average sales price plus 6% for drugs and biologics that are administered on an outpatient basis. When the effects of federal budget sequestration are factored in, that pay rate drops by 2%, which means that oncologists are often barely able to cover the cost of a drug, according to an American Society of Clinical Oncology policy expert who spoke on background.

The final rule also requires outpatient departments to collect data on several new performance measures, including influenza vaccination among health care personnel, appropriate follow-up intervals for normal colonoscopy in average-risk patients, avoidance of inappropriate use of colonoscopy follow-up in patients with a history of polyps, and improvement in visual function within 90 days of cataract surgery.

Ambulatory surgical centers (ASCs)will have to collect data on the two colonoscopy measures and the cataract measure. The data will be used to set payments in 2016.

The CMS removed the requirement that hospitals document referrals from the outpatient setting to cardiac rehabilitation, saying that it was too burdensome.

The final rule also established the performance period (all of 2014) and baseline period (all of 2012) for measuring catheter-associated urinary tract infection, central line-associated bloodstream infection, and surgical site infection measures for the Hospital Value-Based Purchasing Program in 2016.

The final Hospital Outpatient Prospective Payment System (OPPS) rule applies to more than 4,000 hospitals, including general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children’s hospitals, and cancer hospitals, and also 5,000 Medicare-participating ASCs. The OPPS covers most outpatient services, and partial hospitalization at outpatient departments and community mental health centers. The CMS estimates that in 2014, the agency will pay $50 billion for outpatient procedures and about $4 billion for ASC procedures.

The rule is open for comment at www.regulations.gov until Jan. 27, 2014.

[email protected]

On Twitter @aliciaault

Starting in 2015, primary care physicians will get paid for some of the chronic care management work they do outside of office visits.

As part of the 2014 Medicare physician fee schedule final rule, officials at the Centers for Medicare and Medicaid Services (CMS) finalized plans to begin paying physicians separately for services such as development and revision of a care plan, communication with other treating providers, review of lab results, and adjustment of medications.

The agency established a new G-code that physicians can use to bill for non-face-to-face care management services for Medicare patients with two or more significant chronic conditions. The code, which will apply to 20 minutes or more of chronic care management services during a 30-day period, takes effect on Jan. 1, 2015.

Physicians who wish to use the new code will have to meet a series of requirements laid out by the CMS, including providing 24-7 access, coordination with home- and community-based service providers, and patient access to the practice through secure messaging or patient portals.

The new codes are part of a recent move by Medicare officials to emphasize primary care and to pay for services that happen outside of the traditional office visit. In 2012, the CMS established codes for transitional care management services for patients moving from a hospital or skilled nursing facility to home. Those codes, which took effect this year, included payment for some non-face-to-face activities.

The news was greeted as a step in the right direction by the American Academy of Family Physicians.

"Elderly and disabled patients have complex, multiple, and chronic health conditions that require the whole-person medical attention available only through primary care physicians," Dr. Reid Blackwelder, AAFP president, said in a statement. "Placing appropriate value on the primary care services these patients require and establishing codes for chronic care management are important steps in meeting their needs."

The final fee schedule rule also provides a new estimate for how deep the Sustainable Growth Rate (SGR) formula cut will be in 2014. The across-the-board cut, which will take effect on Jan. 1 unless Congress takes action to avert it, will be 20.1%, down from an earlier estimate of 24.4%.

The somewhat smaller cut was not seen as good news by physician groups, which are increasingly fed up with the SGR formula.

The American Medical Association urged Congress to act quickly, not on a temporary patch, but on a permanent repeal of the SGR formula.

"The clock is ticking," Dr. Ardis Dee Hoven, AMA president, said in a statement. "At stake are innovations that would make Medicare more cost effective for current and future generations of seniors. These innovations are not possible if physicians are worried about drastic cuts to Medicare rates that have remained almost flat since 2001, while the cost of caring for patients has gone up by 25 percent."

The 2014 fee schedule also continues to phase in the Physician Value-Based Payment Modifier program. The program links Medicare payments to performance on cost and quality of care. The first payment adjustments will come in January 2015 for practices of 100 or more providers. In January 2016, the program will extend to groups with 10 or more eligible professionals. The CMS estimates that nearly 60% of physicians will be paid under the value-based payment modifier program in 2016. The remainder of physicians will be included in the program starting in January 2017.

But the CMS urged physicians to plan ahead. While payments won’t be affected until those dates, the performance measurement will occur earlier. For instance, for small group practices that will enter the program in 2017, the performance year is 2015. Physicians in small practices should use 2014 as a "practice year" and report to the Physician Quality Reporting System (PQRS) program so that they will be ready in 2015, according to the CMS.

The fee schedule will be published in the Federal Register on Dec. 10. The deadline for public comments on the rule is Jan. 27, 2014.

[email protected]

Starting in 2015, primary care physicians will get paid for some of the chronic care management work they do outside of office visits.

As part of the 2014 Medicare physician fee schedule final rule, officials at the Centers for Medicare and Medicaid Services (CMS) finalized plans to begin paying physicians separately for services such as development and revision of a care plan, communication with other treating providers, review of lab results, and adjustment of medications.

The agency established a new G-code that physicians can use to bill for non-face-to-face care management services for Medicare patients with two or more significant chronic conditions. The code, which will apply to 20 minutes or more of chronic care management services during a 30-day period, takes effect on Jan. 1, 2015.

Physicians who wish to use the new code will have to meet a series of requirements laid out by the CMS, including providing 24-7 access, coordination with home- and community-based service providers, and patient access to the practice through secure messaging or patient portals.

The new codes are part of a recent move by Medicare officials to emphasize primary care and to pay for services that happen outside of the traditional office visit. In 2012, the CMS established codes for transitional care management services for patients moving from a hospital or skilled nursing facility to home. Those codes, which took effect this year, included payment for some non-face-to-face activities.

The news was greeted as a step in the right direction by the American Academy of Family Physicians.

"Elderly and disabled patients have complex, multiple, and chronic health conditions that require the whole-person medical attention available only through primary care physicians," Dr. Reid Blackwelder, AAFP president, said in a statement. "Placing appropriate value on the primary care services these patients require and establishing codes for chronic care management are important steps in meeting their needs."

The final fee schedule rule also provides a new estimate for how deep the Sustainable Growth Rate (SGR) formula cut will be in 2014. The across-the-board cut, which will take effect on Jan. 1 unless Congress takes action to avert it, will be 20.1%, down from an earlier estimate of 24.4%.

The somewhat smaller cut was not seen as good news by physician groups, which are increasingly fed up with the SGR formula.

The American Medical Association urged Congress to act quickly, not on a temporary patch, but on a permanent repeal of the SGR formula.

"The clock is ticking," Dr. Ardis Dee Hoven, AMA president, said in a statement. "At stake are innovations that would make Medicare more cost effective for current and future generations of seniors. These innovations are not possible if physicians are worried about drastic cuts to Medicare rates that have remained almost flat since 2001, while the cost of caring for patients has gone up by 25 percent."

The 2014 fee schedule also continues to phase in the Physician Value-Based Payment Modifier program. The program links Medicare payments to performance on cost and quality of care. The first payment adjustments will come in January 2015 for practices of 100 or more providers. In January 2016, the program will extend to groups with 10 or more eligible professionals. The CMS estimates that nearly 60% of physicians will be paid under the value-based payment modifier program in 2016. The remainder of physicians will be included in the program starting in January 2017.

But the CMS urged physicians to plan ahead. While payments won’t be affected until those dates, the performance measurement will occur earlier. For instance, for small group practices that will enter the program in 2017, the performance year is 2015. Physicians in small practices should use 2014 as a "practice year" and report to the Physician Quality Reporting System (PQRS) program so that they will be ready in 2015, according to the CMS.

The fee schedule will be published in the Federal Register on Dec. 10. The deadline for public comments on the rule is Jan. 27, 2014.

[email protected]

Starting in 2015, primary care physicians will get paid for some of the chronic care management work they do outside of office visits.

As part of the 2014 Medicare physician fee schedule final rule, officials at the Centers for Medicare and Medicaid Services (CMS) finalized plans to begin paying physicians separately for services such as development and revision of a care plan, communication with other treating providers, review of lab results, and adjustment of medications.

The agency established a new G-code that physicians can use to bill for non-face-to-face care management services for Medicare patients with two or more significant chronic conditions. The code, which will apply to 20 minutes or more of chronic care management services during a 30-day period, takes effect on Jan. 1, 2015.

Physicians who wish to use the new code will have to meet a series of requirements laid out by the CMS, including providing 24-7 access, coordination with home- and community-based service providers, and patient access to the practice through secure messaging or patient portals.

The new codes are part of a recent move by Medicare officials to emphasize primary care and to pay for services that happen outside of the traditional office visit. In 2012, the CMS established codes for transitional care management services for patients moving from a hospital or skilled nursing facility to home. Those codes, which took effect this year, included payment for some non-face-to-face activities.

The news was greeted as a step in the right direction by the American Academy of Family Physicians.

"Elderly and disabled patients have complex, multiple, and chronic health conditions that require the whole-person medical attention available only through primary care physicians," Dr. Reid Blackwelder, AAFP president, said in a statement. "Placing appropriate value on the primary care services these patients require and establishing codes for chronic care management are important steps in meeting their needs."

The final fee schedule rule also provides a new estimate for how deep the Sustainable Growth Rate (SGR) formula cut will be in 2014. The across-the-board cut, which will take effect on Jan. 1 unless Congress takes action to avert it, will be 20.1%, down from an earlier estimate of 24.4%.

The somewhat smaller cut was not seen as good news by physician groups, which are increasingly fed up with the SGR formula.

The American Medical Association urged Congress to act quickly, not on a temporary patch, but on a permanent repeal of the SGR formula.

"The clock is ticking," Dr. Ardis Dee Hoven, AMA president, said in a statement. "At stake are innovations that would make Medicare more cost effective for current and future generations of seniors. These innovations are not possible if physicians are worried about drastic cuts to Medicare rates that have remained almost flat since 2001, while the cost of caring for patients has gone up by 25 percent."

The 2014 fee schedule also continues to phase in the Physician Value-Based Payment Modifier program. The program links Medicare payments to performance on cost and quality of care. The first payment adjustments will come in January 2015 for practices of 100 or more providers. In January 2016, the program will extend to groups with 10 or more eligible professionals. The CMS estimates that nearly 60% of physicians will be paid under the value-based payment modifier program in 2016. The remainder of physicians will be included in the program starting in January 2017.

But the CMS urged physicians to plan ahead. While payments won’t be affected until those dates, the performance measurement will occur earlier. For instance, for small group practices that will enter the program in 2017, the performance year is 2015. Physicians in small practices should use 2014 as a "practice year" and report to the Physician Quality Reporting System (PQRS) program so that they will be ready in 2015, according to the CMS.

The fee schedule will be published in the Federal Register on Dec. 10. The deadline for public comments on the rule is Jan. 27, 2014.

[email protected]

An abrupt and unexpected increase in pump thrombosis has occurred since March 2011 in patients with advanced heart failure who received the HeartMate II left ventricular assist device, according to a report published online Nov. 27 in the New England Journal of Medicine.

Those who develop LVAD thrombosis are at substantial risk of death and morbidity unless the device is replaced or cardiac transplantation is performed, said Dr. Randall C. Starling of the Cleveland Clinic and his associates.

The reason for the sudden rise in pump thrombosis is not yet known, but it may be related to excess "deposition of material (fibrin and denatured protein) in proximity to the inflow bearing" of the device, which has been observed by clinicians in at least three cardiac centers.

"Our data suggest that the HeartMate II may have a more narrow tolerance with respect to thrombus formation than originally understood, and may be vulnerable to the timing and intensity of anticoagulation," Dr. Starling and his colleagues noted.

The HeartMate II, made by Thoratec, is a small axial-flow LVAD that "rapidly became integral in the treatment of patients with advanced heart failure" after it was introduced. Early trials and postmarketing approval studies reported a 2%-4% incidence of thrombosis. But a quality review at the Cleveland Clinic showed a sudden, marked increase in that rate beginning in March 2011.

Researchers at the Cleveland Clinic then pooled their data on the HeartMate II (from October 2004 to February 2013) with data on the device from two other high-volume cardiology centers: Washington University Barnes-Jewish Hospital, St. Louis (January 2004 to April 2013) and Duke University Medical Center, Durham, N.C. (May 2005 to May 2013). They now report on their findings from 895 HeartMate II LVADs implanted in 837 patients during that time.

"The HeartMate II may have a more narrow tolerance with respect to thrombus formation than originally understood, and may be vulnerable to the timing and intensity of anticoagulation..."

The mean patient age was 55 years, and 21% of patients were women.

The primary endpoint of the study was confirmed LVAD thrombosis, defined as a finding at pump replacement, urgent transplantation, or autopsy of a thrombus on the blood-contacting surface of the device, its inflow cannula, or its outflow conduit. A total of 72 such thromboses were found in 66 patients; in addition, 36 cases of suspected thromboses occurred.

The rate of confirmed pump thrombosis was initially stable at roughly 2.2% for several years, then rose steeply after March 2011 to 8.4%. This pattern was seen at all three medical centers and across all the cardiac surgeons at those centers.

The median time interval from implantation to pump thrombosis had been 18.6 months before March 2011, but that rate plummeted to 2.7 months during and after March 2011, Dr. Starling and his associates reported (N. Engl. J. Med. 2013 Nov. 27 [doi: 10.1056/NEJMoa1313385]).

The investigators also reviewed serial measurements of lactate dehydrogenase (LDH) that had been taken in recipients of 568 of the devices. Elevated LDH indicates hemolysis that may herald impending thrombosis.

"The graph of the occurrence of LDH levels above 1000 IU per liter ... was nearly superimposable on the graph of the occurrence of confirmed pump thrombosis. The LDH data showed a parallel tendency for elevations to occur early after implantation beginning in approximately March 2011," they said.

The LDH level typically rose from an average of 540 IU/L to an average of 1,490 IU/L during the weeks leading up to LVAD thrombosis at all three medical centers. This confirms that LDH level is a useful clinical biomarker of hemolysis associated with LVAD thrombosis, the researchers said.

Of the 72 pump thromboses, 11 were managed by heart transplantation and 21 by pump replacement. Of the remaining 40 thromboses, 2 were managed by LVAD removal because left ventricular function had improved, and 38 were managed medically, with augmentation of anticoagulation therapy and thrombolytic agents. This stabilized the clinical course in some patients, but others elected withdrawal of care, citing "futility."

Mortality was 48% among the patients who could not be managed by heart transplantation or pump replacement, and this elevated rate was consistent across the three medical centers.

The reasons for this abrupt, dramatic rise in thromboses associated with the HeartMate II are not known. There were no changes in LVAD implantation techniques at any of the three medical centers during the course of this study, "and we could find no association between pump thrombosis and the surgeon performing the implantation." The design of the HeartMate II was changed during this interval – "modification of the outflow graft and bend relief, inflow conduit, and software" was introduced – but these changes have not been linked to pump thrombosis as yet.

Dr. Starling and his associates did note the deposition of fibrin and denatured protein around the inflow bearing, which could narrow the inflow pathway, "increasing shear stress on the red cells and, if the deposition is large enough, decreasing the ability of the pump to unload the left ventricle." But it remains to be seen whether this or other factors played a role.

"Further investigation of predisposing patient and device factors and preventive and therapeutic strategies are urgently needed to resolve this important safety issue," the investigators said.

They added that a fourth cardiology center, the University of Pennsylvania, Philadelphia, found a similar pattern in a preliminary analysis that was reported as the article went to press. In that report on 150 HeartMate II LVADs implanted in 148 patients between November 2005 and September 2013, there were 15 thrombotic events. "Similar to the findings in our study, the event rate has increased abruptly and unexpectedly, with a rate of confirmed thrombosis that continues to rise," Dr. Starling and his associates said.

Dr. Starling reported ties to Thoratec and HeartWare, and his associates reported ties to Thoratec, HeartWare, Abiomed, and Syncardia.

An abrupt and unexpected increase in pump thrombosis has occurred since March 2011 in patients with advanced heart failure who received the HeartMate II left ventricular assist device, according to a report published online Nov. 27 in the New England Journal of Medicine.

Those who develop LVAD thrombosis are at substantial risk of death and morbidity unless the device is replaced or cardiac transplantation is performed, said Dr. Randall C. Starling of the Cleveland Clinic and his associates.

The reason for the sudden rise in pump thrombosis is not yet known, but it may be related to excess "deposition of material (fibrin and denatured protein) in proximity to the inflow bearing" of the device, which has been observed by clinicians in at least three cardiac centers.

"Our data suggest that the HeartMate II may have a more narrow tolerance with respect to thrombus formation than originally understood, and may be vulnerable to the timing and intensity of anticoagulation," Dr. Starling and his colleagues noted.

The HeartMate II, made by Thoratec, is a small axial-flow LVAD that "rapidly became integral in the treatment of patients with advanced heart failure" after it was introduced. Early trials and postmarketing approval studies reported a 2%-4% incidence of thrombosis. But a quality review at the Cleveland Clinic showed a sudden, marked increase in that rate beginning in March 2011.

Researchers at the Cleveland Clinic then pooled their data on the HeartMate II (from October 2004 to February 2013) with data on the device from two other high-volume cardiology centers: Washington University Barnes-Jewish Hospital, St. Louis (January 2004 to April 2013) and Duke University Medical Center, Durham, N.C. (May 2005 to May 2013). They now report on their findings from 895 HeartMate II LVADs implanted in 837 patients during that time.

"The HeartMate II may have a more narrow tolerance with respect to thrombus formation than originally understood, and may be vulnerable to the timing and intensity of anticoagulation..."

The mean patient age was 55 years, and 21% of patients were women.

The primary endpoint of the study was confirmed LVAD thrombosis, defined as a finding at pump replacement, urgent transplantation, or autopsy of a thrombus on the blood-contacting surface of the device, its inflow cannula, or its outflow conduit. A total of 72 such thromboses were found in 66 patients; in addition, 36 cases of suspected thromboses occurred.

The rate of confirmed pump thrombosis was initially stable at roughly 2.2% for several years, then rose steeply after March 2011 to 8.4%. This pattern was seen at all three medical centers and across all the cardiac surgeons at those centers.

The median time interval from implantation to pump thrombosis had been 18.6 months before March 2011, but that rate plummeted to 2.7 months during and after March 2011, Dr. Starling and his associates reported (N. Engl. J. Med. 2013 Nov. 27 [doi: 10.1056/NEJMoa1313385]).

The investigators also reviewed serial measurements of lactate dehydrogenase (LDH) that had been taken in recipients of 568 of the devices. Elevated LDH indicates hemolysis that may herald impending thrombosis.

"The graph of the occurrence of LDH levels above 1000 IU per liter ... was nearly superimposable on the graph of the occurrence of confirmed pump thrombosis. The LDH data showed a parallel tendency for elevations to occur early after implantation beginning in approximately March 2011," they said.

The LDH level typically rose from an average of 540 IU/L to an average of 1,490 IU/L during the weeks leading up to LVAD thrombosis at all three medical centers. This confirms that LDH level is a useful clinical biomarker of hemolysis associated with LVAD thrombosis, the researchers said.

Of the 72 pump thromboses, 11 were managed by heart transplantation and 21 by pump replacement. Of the remaining 40 thromboses, 2 were managed by LVAD removal because left ventricular function had improved, and 38 were managed medically, with augmentation of anticoagulation therapy and thrombolytic agents. This stabilized the clinical course in some patients, but others elected withdrawal of care, citing "futility."

Mortality was 48% among the patients who could not be managed by heart transplantation or pump replacement, and this elevated rate was consistent across the three medical centers.

The reasons for this abrupt, dramatic rise in thromboses associated with the HeartMate II are not known. There were no changes in LVAD implantation techniques at any of the three medical centers during the course of this study, "and we could find no association between pump thrombosis and the surgeon performing the implantation." The design of the HeartMate II was changed during this interval – "modification of the outflow graft and bend relief, inflow conduit, and software" was introduced – but these changes have not been linked to pump thrombosis as yet.

Dr. Starling and his associates did note the deposition of fibrin and denatured protein around the inflow bearing, which could narrow the inflow pathway, "increasing shear stress on the red cells and, if the deposition is large enough, decreasing the ability of the pump to unload the left ventricle." But it remains to be seen whether this or other factors played a role.

"Further investigation of predisposing patient and device factors and preventive and therapeutic strategies are urgently needed to resolve this important safety issue," the investigators said.

They added that a fourth cardiology center, the University of Pennsylvania, Philadelphia, found a similar pattern in a preliminary analysis that was reported as the article went to press. In that report on 150 HeartMate II LVADs implanted in 148 patients between November 2005 and September 2013, there were 15 thrombotic events. "Similar to the findings in our study, the event rate has increased abruptly and unexpectedly, with a rate of confirmed thrombosis that continues to rise," Dr. Starling and his associates said.

Dr. Starling reported ties to Thoratec and HeartWare, and his associates reported ties to Thoratec, HeartWare, Abiomed, and Syncardia.

An abrupt and unexpected increase in pump thrombosis has occurred since March 2011 in patients with advanced heart failure who received the HeartMate II left ventricular assist device, according to a report published online Nov. 27 in the New England Journal of Medicine.

Those who develop LVAD thrombosis are at substantial risk of death and morbidity unless the device is replaced or cardiac transplantation is performed, said Dr. Randall C. Starling of the Cleveland Clinic and his associates.

The reason for the sudden rise in pump thrombosis is not yet known, but it may be related to excess "deposition of material (fibrin and denatured protein) in proximity to the inflow bearing" of the device, which has been observed by clinicians in at least three cardiac centers.

"Our data suggest that the HeartMate II may have a more narrow tolerance with respect to thrombus formation than originally understood, and may be vulnerable to the timing and intensity of anticoagulation," Dr. Starling and his colleagues noted.

The HeartMate II, made by Thoratec, is a small axial-flow LVAD that "rapidly became integral in the treatment of patients with advanced heart failure" after it was introduced. Early trials and postmarketing approval studies reported a 2%-4% incidence of thrombosis. But a quality review at the Cleveland Clinic showed a sudden, marked increase in that rate beginning in March 2011.

Researchers at the Cleveland Clinic then pooled their data on the HeartMate II (from October 2004 to February 2013) with data on the device from two other high-volume cardiology centers: Washington University Barnes-Jewish Hospital, St. Louis (January 2004 to April 2013) and Duke University Medical Center, Durham, N.C. (May 2005 to May 2013). They now report on their findings from 895 HeartMate II LVADs implanted in 837 patients during that time.

"The HeartMate II may have a more narrow tolerance with respect to thrombus formation than originally understood, and may be vulnerable to the timing and intensity of anticoagulation..."

The mean patient age was 55 years, and 21% of patients were women.

The primary endpoint of the study was confirmed LVAD thrombosis, defined as a finding at pump replacement, urgent transplantation, or autopsy of a thrombus on the blood-contacting surface of the device, its inflow cannula, or its outflow conduit. A total of 72 such thromboses were found in 66 patients; in addition, 36 cases of suspected thromboses occurred.

The rate of confirmed pump thrombosis was initially stable at roughly 2.2% for several years, then rose steeply after March 2011 to 8.4%. This pattern was seen at all three medical centers and across all the cardiac surgeons at those centers.

The median time interval from implantation to pump thrombosis had been 18.6 months before March 2011, but that rate plummeted to 2.7 months during and after March 2011, Dr. Starling and his associates reported (N. Engl. J. Med. 2013 Nov. 27 [doi: 10.1056/NEJMoa1313385]).

The investigators also reviewed serial measurements of lactate dehydrogenase (LDH) that had been taken in recipients of 568 of the devices. Elevated LDH indicates hemolysis that may herald impending thrombosis.

"The graph of the occurrence of LDH levels above 1000 IU per liter ... was nearly superimposable on the graph of the occurrence of confirmed pump thrombosis. The LDH data showed a parallel tendency for elevations to occur early after implantation beginning in approximately March 2011," they said.

The LDH level typically rose from an average of 540 IU/L to an average of 1,490 IU/L during the weeks leading up to LVAD thrombosis at all three medical centers. This confirms that LDH level is a useful clinical biomarker of hemolysis associated with LVAD thrombosis, the researchers said.

Of the 72 pump thromboses, 11 were managed by heart transplantation and 21 by pump replacement. Of the remaining 40 thromboses, 2 were managed by LVAD removal because left ventricular function had improved, and 38 were managed medically, with augmentation of anticoagulation therapy and thrombolytic agents. This stabilized the clinical course in some patients, but others elected withdrawal of care, citing "futility."

Mortality was 48% among the patients who could not be managed by heart transplantation or pump replacement, and this elevated rate was consistent across the three medical centers.

The reasons for this abrupt, dramatic rise in thromboses associated with the HeartMate II are not known. There were no changes in LVAD implantation techniques at any of the three medical centers during the course of this study, "and we could find no association between pump thrombosis and the surgeon performing the implantation." The design of the HeartMate II was changed during this interval – "modification of the outflow graft and bend relief, inflow conduit, and software" was introduced – but these changes have not been linked to pump thrombosis as yet.

Dr. Starling and his associates did note the deposition of fibrin and denatured protein around the inflow bearing, which could narrow the inflow pathway, "increasing shear stress on the red cells and, if the deposition is large enough, decreasing the ability of the pump to unload the left ventricle." But it remains to be seen whether this or other factors played a role.

"Further investigation of predisposing patient and device factors and preventive and therapeutic strategies are urgently needed to resolve this important safety issue," the investigators said.

They added that a fourth cardiology center, the University of Pennsylvania, Philadelphia, found a similar pattern in a preliminary analysis that was reported as the article went to press. In that report on 150 HeartMate II LVADs implanted in 148 patients between November 2005 and September 2013, there were 15 thrombotic events. "Similar to the findings in our study, the event rate has increased abruptly and unexpectedly, with a rate of confirmed thrombosis that continues to rise," Dr. Starling and his associates said.

Dr. Starling reported ties to Thoratec and HeartWare, and his associates reported ties to Thoratec, HeartWare, Abiomed, and Syncardia.

The federal insurance website, HealthCare.gov, is now faster and more reliable, but more work still needs to be done, according to an assessment by the Centers for Medicare and Medicaid Services.

About 80% of users are now able to complete the online application and enrollment process, meeting the goal set by the agency to get the website running smoothly for the majority of users by the end of November, Julie Bataille, director of the office of communications at CMS, said at a Dec. 1 press briefing.

CMS officials reported that they have improved the website’s response times, decreased the per-page error rate, and improved system stability and capacity. The improved performance is a "night and day" difference from how the site operated during October, according to Jeff Zients, a consultant brought in to improve the website.

Response time to user requests has been reduced from about 8 seconds in late October to 1 second on Nov. 30, Ms. Bataille reported. Similar reductions have been made to the error rate (percentage of per page system time outs and failures). In early October, the error rate was more than 6%; on Nov. 30, it was less than 1%.

Site stability also has improved, Ms. Bataille said, meaning that HealthCare.gov is "up" more than 90% of the time now – excluding scheduled maintenance – in comparison to 42.9% of the time in early November.

Federal officials said they are hopeful that the site will be able to handle a surge in users in December as the enrollment deadline approaches for consumers who want insurance coverage on Jan. 1. They have increased capacity on the site to about 50,000 simultaneous users and more than 800,000 users per day.

Mr. Zients said that, even with the improvements, the website may not have enough capacity to handle some peak user loads. As a result, CMS has put in place a queuing system that will serve users in order. The system will e-mail those users who could not get through and invite them back to the site when it’s not as busy.

Mr. Zients said that he expects consumers will continue to encounter glitches. However, the issues should be resolved much quicker now that they will have a rapid response team monitoring and responding to problems 24 hours a day.

[email protected]

On Twitter @MaryEllenNY

The federal insurance website, HealthCare.gov, is now faster and more reliable, but more work still needs to be done, according to an assessment by the Centers for Medicare and Medicaid Services.

About 80% of users are now able to complete the online application and enrollment process, meeting the goal set by the agency to get the website running smoothly for the majority of users by the end of November, Julie Bataille, director of the office of communications at CMS, said at a Dec. 1 press briefing.

CMS officials reported that they have improved the website’s response times, decreased the per-page error rate, and improved system stability and capacity. The improved performance is a "night and day" difference from how the site operated during October, according to Jeff Zients, a consultant brought in to improve the website.

Response time to user requests has been reduced from about 8 seconds in late October to 1 second on Nov. 30, Ms. Bataille reported. Similar reductions have been made to the error rate (percentage of per page system time outs and failures). In early October, the error rate was more than 6%; on Nov. 30, it was less than 1%.

Site stability also has improved, Ms. Bataille said, meaning that HealthCare.gov is "up" more than 90% of the time now – excluding scheduled maintenance – in comparison to 42.9% of the time in early November.

Federal officials said they are hopeful that the site will be able to handle a surge in users in December as the enrollment deadline approaches for consumers who want insurance coverage on Jan. 1. They have increased capacity on the site to about 50,000 simultaneous users and more than 800,000 users per day.

Mr. Zients said that, even with the improvements, the website may not have enough capacity to handle some peak user loads. As a result, CMS has put in place a queuing system that will serve users in order. The system will e-mail those users who could not get through and invite them back to the site when it’s not as busy.

Mr. Zients said that he expects consumers will continue to encounter glitches. However, the issues should be resolved much quicker now that they will have a rapid response team monitoring and responding to problems 24 hours a day.

[email protected]

On Twitter @MaryEllenNY

The federal insurance website, HealthCare.gov, is now faster and more reliable, but more work still needs to be done, according to an assessment by the Centers for Medicare and Medicaid Services.

About 80% of users are now able to complete the online application and enrollment process, meeting the goal set by the agency to get the website running smoothly for the majority of users by the end of November, Julie Bataille, director of the office of communications at CMS, said at a Dec. 1 press briefing.

CMS officials reported that they have improved the website’s response times, decreased the per-page error rate, and improved system stability and capacity. The improved performance is a "night and day" difference from how the site operated during October, according to Jeff Zients, a consultant brought in to improve the website.

Response time to user requests has been reduced from about 8 seconds in late October to 1 second on Nov. 30, Ms. Bataille reported. Similar reductions have been made to the error rate (percentage of per page system time outs and failures). In early October, the error rate was more than 6%; on Nov. 30, it was less than 1%.

Site stability also has improved, Ms. Bataille said, meaning that HealthCare.gov is "up" more than 90% of the time now – excluding scheduled maintenance – in comparison to 42.9% of the time in early November.

Federal officials said they are hopeful that the site will be able to handle a surge in users in December as the enrollment deadline approaches for consumers who want insurance coverage on Jan. 1. They have increased capacity on the site to about 50,000 simultaneous users and more than 800,000 users per day.

Mr. Zients said that, even with the improvements, the website may not have enough capacity to handle some peak user loads. As a result, CMS has put in place a queuing system that will serve users in order. The system will e-mail those users who could not get through and invite them back to the site when it’s not as busy.

Mr. Zients said that he expects consumers will continue to encounter glitches. However, the issues should be resolved much quicker now that they will have a rapid response team monitoring and responding to problems 24 hours a day.

[email protected]

On Twitter @MaryEllenNY