I would like to invite all Vascular Annual Meeting attendees to join us for the Spring Meeting of the Vascular and Endovascular Surgery Society (VESS; formerly Peripheral Vascular Surgery Society). This year’s program will be held on Wednesday, June 8 at 8:00 a.m. and conclude at 4:00 p.m. Dr. Bernadette Aulivola and her Program Committee have selected over 25 outstanding research projects for presentation.

The format of the meeting allows great discussion between the presenters and attendees. As in previous years, the VESS and SVS Program Committees combined to select the best scientific papers for the Vascular Annual Meeting. I am sure you will be delighted with this year’s Vascular Annual Meeting.

Founded in 1976 as a club for young and recently graduated Vascular Surgeons, the society has grown to a national organization and international society boasting well over 1,000 members. Focusing on young vascular surgeons in both academic and community practice, our organization offers excellent educational opportunities and networking for career growth.

This year we are excited to introduce the VESS Women and Diversity Meet the Leaders Program, which matches young surgeons with a leader based on the needs of the young surgeon and the experience of the leader to create a mentoring relationship.

VESS has two important scientific meetings yearly. The Spring Meeting is held in conjunction with the Vascular Annual Meeting. The Annual Meeting is held in the winter and is a highlight for both new and old members.

These meetings are a special time to share research, contribute ideas, learn new technologies, and make lifelong friends. The next Annual Meeting will take place February 2-5, 2017 at the Steamboat Grand in Steamboat, Colo. The Annual Meeting will feature interesting interactive programs, engaging speakers, and exciting social events. With nearly 3,000 skiable acres, and featuring night skiing too, it will be an outstanding venue for both education and relaxation. I encourage you to take advantage of the unique setting the Annual Meeting offers. Don’t miss this great vascular meeting in a great setting.

Our members strive to promote basic and clinical research that directly improves outcomes for our vascular and endovascular surgery patients. If you are not a member, please consider joining. You won’t be disappointed. Our new website is www.vesurgery.org. I look forward to seeing you at one of our meetings and encourage you to get involved in this terrific Society!

Thomas Maldonado, MD
VESS President

I would like to invite all Vascular Annual Meeting attendees to join us for the Spring Meeting of the Vascular and Endovascular Surgery Society (VESS; formerly Peripheral Vascular Surgery Society). This year’s program will be held on Wednesday, June 8 at 8:00 a.m. and conclude at 4:00 p.m. Dr. Bernadette Aulivola and her Program Committee have selected over 25 outstanding research projects for presentation.

The format of the meeting allows great discussion between the presenters and attendees. As in previous years, the VESS and SVS Program Committees combined to select the best scientific papers for the Vascular Annual Meeting. I am sure you will be delighted with this year’s Vascular Annual Meeting.

Founded in 1976 as a club for young and recently graduated Vascular Surgeons, the society has grown to a national organization and international society boasting well over 1,000 members. Focusing on young vascular surgeons in both academic and community practice, our organization offers excellent educational opportunities and networking for career growth.

This year we are excited to introduce the VESS Women and Diversity Meet the Leaders Program, which matches young surgeons with a leader based on the needs of the young surgeon and the experience of the leader to create a mentoring relationship.

VESS has two important scientific meetings yearly. The Spring Meeting is held in conjunction with the Vascular Annual Meeting. The Annual Meeting is held in the winter and is a highlight for both new and old members.

These meetings are a special time to share research, contribute ideas, learn new technologies, and make lifelong friends. The next Annual Meeting will take place February 2-5, 2017 at the Steamboat Grand in Steamboat, Colo. The Annual Meeting will feature interesting interactive programs, engaging speakers, and exciting social events. With nearly 3,000 skiable acres, and featuring night skiing too, it will be an outstanding venue for both education and relaxation. I encourage you to take advantage of the unique setting the Annual Meeting offers. Don’t miss this great vascular meeting in a great setting.

Our members strive to promote basic and clinical research that directly improves outcomes for our vascular and endovascular surgery patients. If you are not a member, please consider joining. You won’t be disappointed. Our new website is www.vesurgery.org. I look forward to seeing you at one of our meetings and encourage you to get involved in this terrific Society!

Thomas Maldonado, MD
VESS President

I would like to invite all Vascular Annual Meeting attendees to join us for the Spring Meeting of the Vascular and Endovascular Surgery Society (VESS; formerly Peripheral Vascular Surgery Society). This year’s program will be held on Wednesday, June 8 at 8:00 a.m. and conclude at 4:00 p.m. Dr. Bernadette Aulivola and her Program Committee have selected over 25 outstanding research projects for presentation.

The format of the meeting allows great discussion between the presenters and attendees. As in previous years, the VESS and SVS Program Committees combined to select the best scientific papers for the Vascular Annual Meeting. I am sure you will be delighted with this year’s Vascular Annual Meeting.

Founded in 1976 as a club for young and recently graduated Vascular Surgeons, the society has grown to a national organization and international society boasting well over 1,000 members. Focusing on young vascular surgeons in both academic and community practice, our organization offers excellent educational opportunities and networking for career growth.

This year we are excited to introduce the VESS Women and Diversity Meet the Leaders Program, which matches young surgeons with a leader based on the needs of the young surgeon and the experience of the leader to create a mentoring relationship.

VESS has two important scientific meetings yearly. The Spring Meeting is held in conjunction with the Vascular Annual Meeting. The Annual Meeting is held in the winter and is a highlight for both new and old members.

These meetings are a special time to share research, contribute ideas, learn new technologies, and make lifelong friends. The next Annual Meeting will take place February 2-5, 2017 at the Steamboat Grand in Steamboat, Colo. The Annual Meeting will feature interesting interactive programs, engaging speakers, and exciting social events. With nearly 3,000 skiable acres, and featuring night skiing too, it will be an outstanding venue for both education and relaxation. I encourage you to take advantage of the unique setting the Annual Meeting offers. Don’t miss this great vascular meeting in a great setting.

Our members strive to promote basic and clinical research that directly improves outcomes for our vascular and endovascular surgery patients. If you are not a member, please consider joining. You won’t be disappointed. Our new website is www.vesurgery.org. I look forward to seeing you at one of our meetings and encourage you to get involved in this terrific Society!

Thomas Maldonado, MD
VESS President

(Reuters Health) - Patients in the emergency room who don't speak English well are slightly more likely to return within days, suggesting their care the first time was not as good as it could have been, researchers say.

In a study in one New York hospital, about 4 percent of English speakers made an unplanned return to the ER within three days, compared to 5 percent of people with limited English.

Low use of professional translators may partly explain the disparity in care, the researchers report in the Annals of Emergency Medicine.

"There's a necessary but not sufficient step to providing care for people with low English proficiency . . . having a good interpreter or healthcare provider who can speak to them in their language," said Dr. Elizabeth Jacobs of the University of Wisconsin-Madison, who was not part of the new study.

The study team, led by Dr. Ka Ming Ngai of the Icahn School of Medicine at Mount Sinai in New York, analyzed 2012 data from the Mount Sinai emergency department. More than 32,000 adult patients and 45,000 ER visits were included. The study did not include patients with psychiatric or substance-related

complaints, those who were nonverbal or had altered mental status, and those with a history of frequent ER visits.

Almost 3,000 patients had limited English proficiency, and in about half of cases someone served as an interpreter. Usually, this was a family member or an ER staff member. Only 527 visits in this group, 24 percent, involved a professional interpreter.

More than a quarter of patients were admitted to the hospital and 1,380 patients had an unplanned return to the ER within three days.

After accounting for age, sex, insurance, race, ethnicity, triage category and other health problems, having limited English proficiency was not tied to greater risk of being admitted to the hospital.

But those with limited English proficiency were about 24 percent more likely to return to the ER unexpectedly.

Ngai told Reuters Health by email that he has been studying the problem of language barriers for the past six years and over time has seen some improvements.

"New medical students are now routinely educated to use interpreter phones during their clinical simulation . . .however, there are still many barriers including access to interpreters and interpreter phones, time constraints, and (doctors) trying to 'get by' with their own language skills," he said.

Ngai said regulatory bodies require hospitals to make language services available. In New York State, for example, upon a request to the hospital administration by the patient, the patient's family or representative, or the provider of medical care, hospitals must provide translation services in inpatient and outpatient settings within 20 minutes and in emergency settings with 10 minutes.

Most New York Hospitals use an interpreter phone service, he said.

Patients who struggle to speak the local language are "a really important population to study and think about how we can improve their care," Jacobs said.

A 5 percent rather than 4 percent rate of return to the ER is not a large difference, but that could be due to the large number of patients excluded from the study, and because there was no validated measure of English proficiency, Jacobs said.

"That might be why we didn't see large differences, if some people considered low English proficiency actually spoke English well, or were getting good interpretive services," she said. "If you took them out, the difference might be larger."

Patients who do not speak English may struggle in other areas of the health system more than at the ER, she added.

But even having an interpreter at the hospital won't help patients deal with insurance providers, she noted.

"There are contextual issues that you may not be able to fully adequately address unless you can understand the nuances," Jacobs said.

"When dealing with immigrant population, it is almost always more than 'just' language," Ngai agreed. There can be cultural issues, too.

In addition, people with low English proficiency may also be less able to take days off of work, and to agree to be admitted to the hospital when necessary, than others, Jacobs said.

We've made tremendous progress in assuring interpreters are more available," in person, over the phone or by video, Jacobs said.

But, she said, "we are very imperfect at getting patients the services they need. It's important for providers to be educated on these issues and to understand how to access these services."

It would be ideal to try to match patients with providers by language and culture, but in the meantime, "language is a good start," Ngai said.

(Reuters Health) - Patients in the emergency room who don't speak English well are slightly more likely to return within days, suggesting their care the first time was not as good as it could have been, researchers say.

In a study in one New York hospital, about 4 percent of English speakers made an unplanned return to the ER within three days, compared to 5 percent of people with limited English.

Low use of professional translators may partly explain the disparity in care, the researchers report in the Annals of Emergency Medicine.

"There's a necessary but not sufficient step to providing care for people with low English proficiency . . . having a good interpreter or healthcare provider who can speak to them in their language," said Dr. Elizabeth Jacobs of the University of Wisconsin-Madison, who was not part of the new study.

The study team, led by Dr. Ka Ming Ngai of the Icahn School of Medicine at Mount Sinai in New York, analyzed 2012 data from the Mount Sinai emergency department. More than 32,000 adult patients and 45,000 ER visits were included. The study did not include patients with psychiatric or substance-related

complaints, those who were nonverbal or had altered mental status, and those with a history of frequent ER visits.

Almost 3,000 patients had limited English proficiency, and in about half of cases someone served as an interpreter. Usually, this was a family member or an ER staff member. Only 527 visits in this group, 24 percent, involved a professional interpreter.

More than a quarter of patients were admitted to the hospital and 1,380 patients had an unplanned return to the ER within three days.

After accounting for age, sex, insurance, race, ethnicity, triage category and other health problems, having limited English proficiency was not tied to greater risk of being admitted to the hospital.

But those with limited English proficiency were about 24 percent more likely to return to the ER unexpectedly.

Ngai told Reuters Health by email that he has been studying the problem of language barriers for the past six years and over time has seen some improvements.

"New medical students are now routinely educated to use interpreter phones during their clinical simulation . . .however, there are still many barriers including access to interpreters and interpreter phones, time constraints, and (doctors) trying to 'get by' with their own language skills," he said.

Ngai said regulatory bodies require hospitals to make language services available. In New York State, for example, upon a request to the hospital administration by the patient, the patient's family or representative, or the provider of medical care, hospitals must provide translation services in inpatient and outpatient settings within 20 minutes and in emergency settings with 10 minutes.

Most New York Hospitals use an interpreter phone service, he said.

Patients who struggle to speak the local language are "a really important population to study and think about how we can improve their care," Jacobs said.

A 5 percent rather than 4 percent rate of return to the ER is not a large difference, but that could be due to the large number of patients excluded from the study, and because there was no validated measure of English proficiency, Jacobs said.

"That might be why we didn't see large differences, if some people considered low English proficiency actually spoke English well, or were getting good interpretive services," she said. "If you took them out, the difference might be larger."

Patients who do not speak English may struggle in other areas of the health system more than at the ER, she added.

But even having an interpreter at the hospital won't help patients deal with insurance providers, she noted.

"There are contextual issues that you may not be able to fully adequately address unless you can understand the nuances," Jacobs said.

"When dealing with immigrant population, it is almost always more than 'just' language," Ngai agreed. There can be cultural issues, too.

In addition, people with low English proficiency may also be less able to take days off of work, and to agree to be admitted to the hospital when necessary, than others, Jacobs said.

We've made tremendous progress in assuring interpreters are more available," in person, over the phone or by video, Jacobs said.

But, she said, "we are very imperfect at getting patients the services they need. It's important for providers to be educated on these issues and to understand how to access these services."

It would be ideal to try to match patients with providers by language and culture, but in the meantime, "language is a good start," Ngai said.

(Reuters Health) - Patients in the emergency room who don't speak English well are slightly more likely to return within days, suggesting their care the first time was not as good as it could have been, researchers say.

In a study in one New York hospital, about 4 percent of English speakers made an unplanned return to the ER within three days, compared to 5 percent of people with limited English.

Low use of professional translators may partly explain the disparity in care, the researchers report in the Annals of Emergency Medicine.

"There's a necessary but not sufficient step to providing care for people with low English proficiency . . . having a good interpreter or healthcare provider who can speak to them in their language," said Dr. Elizabeth Jacobs of the University of Wisconsin-Madison, who was not part of the new study.

The study team, led by Dr. Ka Ming Ngai of the Icahn School of Medicine at Mount Sinai in New York, analyzed 2012 data from the Mount Sinai emergency department. More than 32,000 adult patients and 45,000 ER visits were included. The study did not include patients with psychiatric or substance-related

complaints, those who were nonverbal or had altered mental status, and those with a history of frequent ER visits.

Almost 3,000 patients had limited English proficiency, and in about half of cases someone served as an interpreter. Usually, this was a family member or an ER staff member. Only 527 visits in this group, 24 percent, involved a professional interpreter.

More than a quarter of patients were admitted to the hospital and 1,380 patients had an unplanned return to the ER within three days.

After accounting for age, sex, insurance, race, ethnicity, triage category and other health problems, having limited English proficiency was not tied to greater risk of being admitted to the hospital.

But those with limited English proficiency were about 24 percent more likely to return to the ER unexpectedly.

Ngai told Reuters Health by email that he has been studying the problem of language barriers for the past six years and over time has seen some improvements.

"New medical students are now routinely educated to use interpreter phones during their clinical simulation . . .however, there are still many barriers including access to interpreters and interpreter phones, time constraints, and (doctors) trying to 'get by' with their own language skills," he said.

Ngai said regulatory bodies require hospitals to make language services available. In New York State, for example, upon a request to the hospital administration by the patient, the patient's family or representative, or the provider of medical care, hospitals must provide translation services in inpatient and outpatient settings within 20 minutes and in emergency settings with 10 minutes.

Most New York Hospitals use an interpreter phone service, he said.

Patients who struggle to speak the local language are "a really important population to study and think about how we can improve their care," Jacobs said.

A 5 percent rather than 4 percent rate of return to the ER is not a large difference, but that could be due to the large number of patients excluded from the study, and because there was no validated measure of English proficiency, Jacobs said.

"That might be why we didn't see large differences, if some people considered low English proficiency actually spoke English well, or were getting good interpretive services," she said. "If you took them out, the difference might be larger."

Patients who do not speak English may struggle in other areas of the health system more than at the ER, she added.

But even having an interpreter at the hospital won't help patients deal with insurance providers, she noted.

"There are contextual issues that you may not be able to fully adequately address unless you can understand the nuances," Jacobs said.

"When dealing with immigrant population, it is almost always more than 'just' language," Ngai agreed. There can be cultural issues, too.

In addition, people with low English proficiency may also be less able to take days off of work, and to agree to be admitted to the hospital when necessary, than others, Jacobs said.

We've made tremendous progress in assuring interpreters are more available," in person, over the phone or by video, Jacobs said.

But, she said, "we are very imperfect at getting patients the services they need. It's important for providers to be educated on these issues and to understand how to access these services."

It would be ideal to try to match patients with providers by language and culture, but in the meantime, "language is a good start," Ngai said.

Blood drop

CINCINNATI—Researchers say they have developed a lateral flow assay device that patients can use at home to monitor their blood coagulation.

The device consists of nanofiber membranes inside a paper-based, porous test strip that is housed in a plastic cassette.

The researchers said this device can quickly reveal the level of the blood’s ability to clot using just a drop of blood from a finger prick.

“We have developed a blood-screening device for patients on medications like Coumadin (warfarin) or other blood thinners who need to monitor their blood-clotting levels on a regular basis,” said Andrew Steckl, PhD, of the University of Cincinnati in Ohio.

“Patients can soon monitor their blood coagulation characteristics from home quickly and painlessly before making needless trips to the lab or hospital.”

Hua Li, a student researcher in Dr Steckl’s lab, presented details on this device at the 8th International Conference on Porous Media and Annual Meeting of the International Society for Porous Media (abstract 1371).

Dr Steckl noted that slight changes in the level of coagulation properties will occur normally, but a major change in levels immediately shows up with his team’s device.

The researchers found the device was able to detect coagulation ability in rabbit blood and in blood from patients receiving warfarin.

“This simple test is not intended to replace the very careful and accurate measurements that get accomplished in a laboratory facility, but, at a relatively minimal cost, a patient can do this on their own between scheduled visits or when in doubt,” Dr Steckl said. “And it shouldn’t require a caregiver, as most patients can perform this test quickly on their own.”

Furthermore, the researchers said this technology can be calibrated to a specific patient’s condition. For example, a patient whose normal blood coagulation rate is significantly different from the general population because of a genetic disorder can use a tailor-made test kit that includes a different porous membrane.

The technology may also help patients who have a known inherited blood clotting disorder detect concerning levels early.

“By identifying potential blood-clotting problems early enough, we hope to prevent potential injury or death and the exorbitant associated costs,” Dr Steckl said. “By shifting from what were once mandatory expensive laboratory tests to using more in-home screening tests, patients can take more control of their lives, reduce healthcare costs, and, ultimately, save more lives.”

Blood drop

CINCINNATI—Researchers say they have developed a lateral flow assay device that patients can use at home to monitor their blood coagulation.

The device consists of nanofiber membranes inside a paper-based, porous test strip that is housed in a plastic cassette.

The researchers said this device can quickly reveal the level of the blood’s ability to clot using just a drop of blood from a finger prick.

“We have developed a blood-screening device for patients on medications like Coumadin (warfarin) or other blood thinners who need to monitor their blood-clotting levels on a regular basis,” said Andrew Steckl, PhD, of the University of Cincinnati in Ohio.

“Patients can soon monitor their blood coagulation characteristics from home quickly and painlessly before making needless trips to the lab or hospital.”

Hua Li, a student researcher in Dr Steckl’s lab, presented details on this device at the 8th International Conference on Porous Media and Annual Meeting of the International Society for Porous Media (abstract 1371).

Dr Steckl noted that slight changes in the level of coagulation properties will occur normally, but a major change in levels immediately shows up with his team’s device.

The researchers found the device was able to detect coagulation ability in rabbit blood and in blood from patients receiving warfarin.

“This simple test is not intended to replace the very careful and accurate measurements that get accomplished in a laboratory facility, but, at a relatively minimal cost, a patient can do this on their own between scheduled visits or when in doubt,” Dr Steckl said. “And it shouldn’t require a caregiver, as most patients can perform this test quickly on their own.”

Furthermore, the researchers said this technology can be calibrated to a specific patient’s condition. For example, a patient whose normal blood coagulation rate is significantly different from the general population because of a genetic disorder can use a tailor-made test kit that includes a different porous membrane.

The technology may also help patients who have a known inherited blood clotting disorder detect concerning levels early.

“By identifying potential blood-clotting problems early enough, we hope to prevent potential injury or death and the exorbitant associated costs,” Dr Steckl said. “By shifting from what were once mandatory expensive laboratory tests to using more in-home screening tests, patients can take more control of their lives, reduce healthcare costs, and, ultimately, save more lives.”

Blood drop

CINCINNATI—Researchers say they have developed a lateral flow assay device that patients can use at home to monitor their blood coagulation.

The device consists of nanofiber membranes inside a paper-based, porous test strip that is housed in a plastic cassette.

The researchers said this device can quickly reveal the level of the blood’s ability to clot using just a drop of blood from a finger prick.

“We have developed a blood-screening device for patients on medications like Coumadin (warfarin) or other blood thinners who need to monitor their blood-clotting levels on a regular basis,” said Andrew Steckl, PhD, of the University of Cincinnati in Ohio.

“Patients can soon monitor their blood coagulation characteristics from home quickly and painlessly before making needless trips to the lab or hospital.”

Hua Li, a student researcher in Dr Steckl’s lab, presented details on this device at the 8th International Conference on Porous Media and Annual Meeting of the International Society for Porous Media (abstract 1371).

Dr Steckl noted that slight changes in the level of coagulation properties will occur normally, but a major change in levels immediately shows up with his team’s device.

The researchers found the device was able to detect coagulation ability in rabbit blood and in blood from patients receiving warfarin.

“This simple test is not intended to replace the very careful and accurate measurements that get accomplished in a laboratory facility, but, at a relatively minimal cost, a patient can do this on their own between scheduled visits or when in doubt,” Dr Steckl said. “And it shouldn’t require a caregiver, as most patients can perform this test quickly on their own.”

Furthermore, the researchers said this technology can be calibrated to a specific patient’s condition. For example, a patient whose normal blood coagulation rate is significantly different from the general population because of a genetic disorder can use a tailor-made test kit that includes a different porous membrane.

The technology may also help patients who have a known inherited blood clotting disorder detect concerning levels early.

“By identifying potential blood-clotting problems early enough, we hope to prevent potential injury or death and the exorbitant associated costs,” Dr Steckl said. “By shifting from what were once mandatory expensive laboratory tests to using more in-home screening tests, patients can take more control of their lives, reduce healthcare costs, and, ultimately, save more lives.”

Urine sample

The US Centers for Disease Control and Prevention (CDC) has released an interim guidance for testing urine for the Zika virus.

The agency noted that, in most patients, Zika virus RNA is unlikely to be detected in serum after the first week of illness.

However, recent reports have suggested that Zika virus RNA can be detected in urine for at least 2 weeks after the onset of symptoms.

Therefore, the CDC recommends that real-time reverse transcription–polymerase chain reaction (rRT-PCR) be performed on urine collected less than 14 days after the onset of symptoms in patients with suspected Zika virus.

The agency said further investigation is needed to determine the utility of rRT-PCR on urine specimens collected at 14 days or beyond.

The CDC also recommends that urine testing be performed in conjunction with serum testing for specimens collected less than 7 days after symptom onset. The agency said its recommendations for testing serum and other clinical specimens for Zika virus have not changed.

At present, the CDC’s Trioplex rRT-PCR assay is the only diagnostic tool authorized by the US Food and Drug Administration to test urine for Zika virus.

Urine sample

The US Centers for Disease Control and Prevention (CDC) has released an interim guidance for testing urine for the Zika virus.

The agency noted that, in most patients, Zika virus RNA is unlikely to be detected in serum after the first week of illness.

However, recent reports have suggested that Zika virus RNA can be detected in urine for at least 2 weeks after the onset of symptoms.

Therefore, the CDC recommends that real-time reverse transcription–polymerase chain reaction (rRT-PCR) be performed on urine collected less than 14 days after the onset of symptoms in patients with suspected Zika virus.

The agency said further investigation is needed to determine the utility of rRT-PCR on urine specimens collected at 14 days or beyond.

The CDC also recommends that urine testing be performed in conjunction with serum testing for specimens collected less than 7 days after symptom onset. The agency said its recommendations for testing serum and other clinical specimens for Zika virus have not changed.

At present, the CDC’s Trioplex rRT-PCR assay is the only diagnostic tool authorized by the US Food and Drug Administration to test urine for Zika virus.

Urine sample

The US Centers for Disease Control and Prevention (CDC) has released an interim guidance for testing urine for the Zika virus.

The agency noted that, in most patients, Zika virus RNA is unlikely to be detected in serum after the first week of illness.

However, recent reports have suggested that Zika virus RNA can be detected in urine for at least 2 weeks after the onset of symptoms.

Therefore, the CDC recommends that real-time reverse transcription–polymerase chain reaction (rRT-PCR) be performed on urine collected less than 14 days after the onset of symptoms in patients with suspected Zika virus.

The agency said further investigation is needed to determine the utility of rRT-PCR on urine specimens collected at 14 days or beyond.

The CDC also recommends that urine testing be performed in conjunction with serum testing for specimens collected less than 7 days after symptom onset. The agency said its recommendations for testing serum and other clinical specimens for Zika virus have not changed.

At present, the CDC’s Trioplex rRT-PCR assay is the only diagnostic tool authorized by the US Food and Drug Administration to test urine for Zika virus.

Ibrutinib (Imbruvica)

Photo from Janssen Biotech

Health Canada has approved the BTK inhibitor ibrutinib (Imbruvica) as a treatment for patients with Waldenström’s macroglobulinemia (WM).

Ibrutinib was first approved in Canada in November 2014 for the treatment of patients with chronic lymphocytic leukemia (CLL), including those with 17p deletion, who have received at least one prior therapy, or for the frontline treatment of patients with CLL and 17p deletion.

In July 2015, ibrutinib was granted conditional approval for the treatment of patients with relapsed or refractory mantle cell lymphoma.

Health Canada’s approval of ibrutinib for WM was based on results of a multicenter, phase 2 study in which researchers tested the drug (given at 420 mg once daily) in 63 patients with previously treated WM.

The patients’ median age was 63 (range, 44-86), and their median number of prior therapies was 2 (range, 1-11).

Initial data showed an overall response rate of 87.3% in patients who received ibrutinib for a median of 11.7 months.

Updated results from the study were published in NEJM in April 2015. After a median treatment duration of 19.1 months, the overall response rate was 91%.

At 24 months, the estimated rate of progression-free survival was 69%, and the estimated rate of overall survival was 95%.

The most common grade 2-4 adverse events were neutropenia (22%) and thrombocytopenia (14%). Ibrutinib-related neutropenia and thrombocytopenia were reversible but required a dose reduction in 3 patients and treatment discontinuation in 4 patients.

Grade 2 or higher bleeding events occurred in 4 patients, and there were 15 infections considered possibly related to ibrutinib.

Treatment-related atrial fibrillation (AFib) occurred in 3 patients, all of whom had a prior history of paroxysmal AFib. AFib resolved when treatment was withheld, and all 3 patients were able to continue on therapy per protocol without an additional event.

Ibrutinib is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics LLC, an AbbVie company. Janssen Inc. markets ibrutinib as Imbruvica in Canada.

Ibrutinib (Imbruvica)

Photo from Janssen Biotech

Health Canada has approved the BTK inhibitor ibrutinib (Imbruvica) as a treatment for patients with Waldenström’s macroglobulinemia (WM).

Ibrutinib was first approved in Canada in November 2014 for the treatment of patients with chronic lymphocytic leukemia (CLL), including those with 17p deletion, who have received at least one prior therapy, or for the frontline treatment of patients with CLL and 17p deletion.

In July 2015, ibrutinib was granted conditional approval for the treatment of patients with relapsed or refractory mantle cell lymphoma.

Health Canada’s approval of ibrutinib for WM was based on results of a multicenter, phase 2 study in which researchers tested the drug (given at 420 mg once daily) in 63 patients with previously treated WM.

The patients’ median age was 63 (range, 44-86), and their median number of prior therapies was 2 (range, 1-11).

Initial data showed an overall response rate of 87.3% in patients who received ibrutinib for a median of 11.7 months.

Updated results from the study were published in NEJM in April 2015. After a median treatment duration of 19.1 months, the overall response rate was 91%.

At 24 months, the estimated rate of progression-free survival was 69%, and the estimated rate of overall survival was 95%.

The most common grade 2-4 adverse events were neutropenia (22%) and thrombocytopenia (14%). Ibrutinib-related neutropenia and thrombocytopenia were reversible but required a dose reduction in 3 patients and treatment discontinuation in 4 patients.

Grade 2 or higher bleeding events occurred in 4 patients, and there were 15 infections considered possibly related to ibrutinib.

Treatment-related atrial fibrillation (AFib) occurred in 3 patients, all of whom had a prior history of paroxysmal AFib. AFib resolved when treatment was withheld, and all 3 patients were able to continue on therapy per protocol without an additional event.

Ibrutinib is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics LLC, an AbbVie company. Janssen Inc. markets ibrutinib as Imbruvica in Canada.

Ibrutinib (Imbruvica)

Photo from Janssen Biotech

Health Canada has approved the BTK inhibitor ibrutinib (Imbruvica) as a treatment for patients with Waldenström’s macroglobulinemia (WM).

Ibrutinib was first approved in Canada in November 2014 for the treatment of patients with chronic lymphocytic leukemia (CLL), including those with 17p deletion, who have received at least one prior therapy, or for the frontline treatment of patients with CLL and 17p deletion.

In July 2015, ibrutinib was granted conditional approval for the treatment of patients with relapsed or refractory mantle cell lymphoma.

Health Canada’s approval of ibrutinib for WM was based on results of a multicenter, phase 2 study in which researchers tested the drug (given at 420 mg once daily) in 63 patients with previously treated WM.

The patients’ median age was 63 (range, 44-86), and their median number of prior therapies was 2 (range, 1-11).

Initial data showed an overall response rate of 87.3% in patients who received ibrutinib for a median of 11.7 months.

Updated results from the study were published in NEJM in April 2015. After a median treatment duration of 19.1 months, the overall response rate was 91%.

At 24 months, the estimated rate of progression-free survival was 69%, and the estimated rate of overall survival was 95%.

The most common grade 2-4 adverse events were neutropenia (22%) and thrombocytopenia (14%). Ibrutinib-related neutropenia and thrombocytopenia were reversible but required a dose reduction in 3 patients and treatment discontinuation in 4 patients.

Grade 2 or higher bleeding events occurred in 4 patients, and there were 15 infections considered possibly related to ibrutinib.

Treatment-related atrial fibrillation (AFib) occurred in 3 patients, all of whom had a prior history of paroxysmal AFib. AFib resolved when treatment was withheld, and all 3 patients were able to continue on therapy per protocol without an additional event.

Ibrutinib is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics LLC, an AbbVie company. Janssen Inc. markets ibrutinib as Imbruvica in Canada.

Pediatric cancer patient

Photo by Bill Branson

Adding a physiologic dose of hydrocortisone to treatment with dexamethasone can reduce the severity of certain adverse effects (AEs) in pediatric patients with acute lymphoblastic leukemia (ALL), according to researchers.

Hydrocortisone did not decrease the incidence of psychosocial problems or sleep-related issues in these patients, but the drug did reduce the severity of these problems among patients who experienced them.

Lidewij T. Warris, MD, of Erasmus MC-Sophia Children’s Hospital in Rotterdam, the Netherlands, and her colleagues reported these results in the Journal of Clinical Oncology.

The team conducted this study to determine whether a physiologic dose of hydrocortisone could reduce neuropsychologic and metabolic AEs in children with ALL who were receiving dexamethasone.

The study enrolled 50 patients (ages 3 to 16) who were set to receive 2 consecutive courses of dexamethasone in accordance with Dutch Childhood Oncology Group ALL protocols.

The patients were randomized to receive either hydrocortisone or placebo in a circadian rhythm (10 mg/m²/d) during their first dexamethasone course. During their second course, the patients were assigned to the opposite arm.

The treatment groups were similar with regard to age, type of leukemia, treatment protocol, and CNS status at diagnosis.

Psychosocial problems

The researchers assessed psychosocial problems by having parents complete the Strength and Difficulties Questionnaire (SDQ). Forty-six parents completed the questionnaire at all 4 time points tested.

The results showed that 4 days of dexamethasone treatment significantly increased patient problems, as reported by all SDQ scales and subscales. However, one-third of the population did not have any increase in SDQ total difficulties with dexamethasone.

The addition of hydrocortisone did not affect patients’ total difficulties score (mean difference, -0.8 ± 5.5; P=0.33), emotional symptoms (mean difference, -0.6 ± 2.3; P=0.08), conduct problems (mean difference, 0.0 ± 1.5; P=1.00), or other SDQ subscales.

However, hydrocortisone did have a clinically significant effect in the subset of 16 patients who had clinically relevant dexamethasone-related AEs. This was defined as an increase of ≥5 in their SDQ total difficulties score.

In these patients, hydrocortisone improved the total difficulties delta-score (median difference, -5.0; IQR, -7.8 to -3.0), emotional symptoms score (median difference, -1.5; IQR, -4.0 to -1.0), conduct problems score (median difference, -1.0; IQR, -2.0 to 0.0), and impact of stress score (median difference, -1.0; IQR, -2.0 to 0.0).

Sleep issues

The researchers used the Sleep Disturbance Scale for Children (SDSC) to assess sleep quality and sleep disturbances. Forty-seven parents completed the questionnaire at all 4 time points tested.

Results showed that dexamethasone significantly increased disorders of arousal (P=0.04), sleep-wake transition disorders (P=0.01), and disorders of excessive somnolence (P=0.01).

The addition of hydrocortisone had no significant effect on patients’ total SDSC score (P=0.84), disorders of initiating and maintaining sleep (P=0.74), disorders of excessive somnolence (P=0.29), or sleep-wake transition disorder (P=0.29).

However, hydrocortisone did have a clinically significant effect in the subset of 9 children who had clinically relevant dexamethasone-induced sleeping problems, which were defined as a change of ≥7 in SDSC total score.

Hydrocortisone reduced SDSC total scores (median difference, -11.0; IQR, -16.0 to 0.0) and disorders of initiating and maintaining sleep scores (median difference, -3.0; IQR, -7.0 to –0.5).

Other outcomes

The researchers also found that dexamethasone treatment alone did not affect patients’ attention, visual-spatial functions, memory, or processing speed.

However, the addition of hydrocortisone significantly improved patients’ long-term visual memory (P=0.01).

Hydrocortisone did not have any effect on other neuropsychological tests or on metabolic parameters.

Pediatric cancer patient

Photo by Bill Branson

Adding a physiologic dose of hydrocortisone to treatment with dexamethasone can reduce the severity of certain adverse effects (AEs) in pediatric patients with acute lymphoblastic leukemia (ALL), according to researchers.

Hydrocortisone did not decrease the incidence of psychosocial problems or sleep-related issues in these patients, but the drug did reduce the severity of these problems among patients who experienced them.

Lidewij T. Warris, MD, of Erasmus MC-Sophia Children’s Hospital in Rotterdam, the Netherlands, and her colleagues reported these results in the Journal of Clinical Oncology.

The team conducted this study to determine whether a physiologic dose of hydrocortisone could reduce neuropsychologic and metabolic AEs in children with ALL who were receiving dexamethasone.

The study enrolled 50 patients (ages 3 to 16) who were set to receive 2 consecutive courses of dexamethasone in accordance with Dutch Childhood Oncology Group ALL protocols.

The patients were randomized to receive either hydrocortisone or placebo in a circadian rhythm (10 mg/m²/d) during their first dexamethasone course. During their second course, the patients were assigned to the opposite arm.

The treatment groups were similar with regard to age, type of leukemia, treatment protocol, and CNS status at diagnosis.

Psychosocial problems

The researchers assessed psychosocial problems by having parents complete the Strength and Difficulties Questionnaire (SDQ). Forty-six parents completed the questionnaire at all 4 time points tested.

The results showed that 4 days of dexamethasone treatment significantly increased patient problems, as reported by all SDQ scales and subscales. However, one-third of the population did not have any increase in SDQ total difficulties with dexamethasone.

The addition of hydrocortisone did not affect patients’ total difficulties score (mean difference, -0.8 ± 5.5; P=0.33), emotional symptoms (mean difference, -0.6 ± 2.3; P=0.08), conduct problems (mean difference, 0.0 ± 1.5; P=1.00), or other SDQ subscales.

However, hydrocortisone did have a clinically significant effect in the subset of 16 patients who had clinically relevant dexamethasone-related AEs. This was defined as an increase of ≥5 in their SDQ total difficulties score.

In these patients, hydrocortisone improved the total difficulties delta-score (median difference, -5.0; IQR, -7.8 to -3.0), emotional symptoms score (median difference, -1.5; IQR, -4.0 to -1.0), conduct problems score (median difference, -1.0; IQR, -2.0 to 0.0), and impact of stress score (median difference, -1.0; IQR, -2.0 to 0.0).

Sleep issues

The researchers used the Sleep Disturbance Scale for Children (SDSC) to assess sleep quality and sleep disturbances. Forty-seven parents completed the questionnaire at all 4 time points tested.

Results showed that dexamethasone significantly increased disorders of arousal (P=0.04), sleep-wake transition disorders (P=0.01), and disorders of excessive somnolence (P=0.01).

The addition of hydrocortisone had no significant effect on patients’ total SDSC score (P=0.84), disorders of initiating and maintaining sleep (P=0.74), disorders of excessive somnolence (P=0.29), or sleep-wake transition disorder (P=0.29).

However, hydrocortisone did have a clinically significant effect in the subset of 9 children who had clinically relevant dexamethasone-induced sleeping problems, which were defined as a change of ≥7 in SDSC total score.

Hydrocortisone reduced SDSC total scores (median difference, -11.0; IQR, -16.0 to 0.0) and disorders of initiating and maintaining sleep scores (median difference, -3.0; IQR, -7.0 to –0.5).

Other outcomes

The researchers also found that dexamethasone treatment alone did not affect patients’ attention, visual-spatial functions, memory, or processing speed.

However, the addition of hydrocortisone significantly improved patients’ long-term visual memory (P=0.01).

Hydrocortisone did not have any effect on other neuropsychological tests or on metabolic parameters.

Pediatric cancer patient

Photo by Bill Branson

Adding a physiologic dose of hydrocortisone to treatment with dexamethasone can reduce the severity of certain adverse effects (AEs) in pediatric patients with acute lymphoblastic leukemia (ALL), according to researchers.

Hydrocortisone did not decrease the incidence of psychosocial problems or sleep-related issues in these patients, but the drug did reduce the severity of these problems among patients who experienced them.

Lidewij T. Warris, MD, of Erasmus MC-Sophia Children’s Hospital in Rotterdam, the Netherlands, and her colleagues reported these results in the Journal of Clinical Oncology.

The team conducted this study to determine whether a physiologic dose of hydrocortisone could reduce neuropsychologic and metabolic AEs in children with ALL who were receiving dexamethasone.

The study enrolled 50 patients (ages 3 to 16) who were set to receive 2 consecutive courses of dexamethasone in accordance with Dutch Childhood Oncology Group ALL protocols.

The patients were randomized to receive either hydrocortisone or placebo in a circadian rhythm (10 mg/m²/d) during their first dexamethasone course. During their second course, the patients were assigned to the opposite arm.

The treatment groups were similar with regard to age, type of leukemia, treatment protocol, and CNS status at diagnosis.

Psychosocial problems

The researchers assessed psychosocial problems by having parents complete the Strength and Difficulties Questionnaire (SDQ). Forty-six parents completed the questionnaire at all 4 time points tested.

The results showed that 4 days of dexamethasone treatment significantly increased patient problems, as reported by all SDQ scales and subscales. However, one-third of the population did not have any increase in SDQ total difficulties with dexamethasone.

The addition of hydrocortisone did not affect patients’ total difficulties score (mean difference, -0.8 ± 5.5; P=0.33), emotional symptoms (mean difference, -0.6 ± 2.3; P=0.08), conduct problems (mean difference, 0.0 ± 1.5; P=1.00), or other SDQ subscales.

However, hydrocortisone did have a clinically significant effect in the subset of 16 patients who had clinically relevant dexamethasone-related AEs. This was defined as an increase of ≥5 in their SDQ total difficulties score.

In these patients, hydrocortisone improved the total difficulties delta-score (median difference, -5.0; IQR, -7.8 to -3.0), emotional symptoms score (median difference, -1.5; IQR, -4.0 to -1.0), conduct problems score (median difference, -1.0; IQR, -2.0 to 0.0), and impact of stress score (median difference, -1.0; IQR, -2.0 to 0.0).

Sleep issues

The researchers used the Sleep Disturbance Scale for Children (SDSC) to assess sleep quality and sleep disturbances. Forty-seven parents completed the questionnaire at all 4 time points tested.

Results showed that dexamethasone significantly increased disorders of arousal (P=0.04), sleep-wake transition disorders (P=0.01), and disorders of excessive somnolence (P=0.01).

The addition of hydrocortisone had no significant effect on patients’ total SDSC score (P=0.84), disorders of initiating and maintaining sleep (P=0.74), disorders of excessive somnolence (P=0.29), or sleep-wake transition disorder (P=0.29).

However, hydrocortisone did have a clinically significant effect in the subset of 9 children who had clinically relevant dexamethasone-induced sleeping problems, which were defined as a change of ≥7 in SDSC total score.

Hydrocortisone reduced SDSC total scores (median difference, -11.0; IQR, -16.0 to 0.0) and disorders of initiating and maintaining sleep scores (median difference, -3.0; IQR, -7.0 to –0.5).

Other outcomes

The researchers also found that dexamethasone treatment alone did not affect patients’ attention, visual-spatial functions, memory, or processing speed.

However, the addition of hydrocortisone significantly improved patients’ long-term visual memory (P=0.01).

Hydrocortisone did not have any effect on other neuropsychological tests or on metabolic parameters.

Click here for basic information about electroencephalogram (EEG) testing.

Click here for basic information about electroencephalogram (EEG) testing.

Click here for basic information about electroencephalogram (EEG) testing.

By now, most of us have heard of accountable care organizations and bundled payment. But for many of you, the shift to value-based population health management or compensation based on performance hasn’t affected your practice.

You still get paid fee for service. You’ve seen “the next big thing” in health care come and go; you don’t have the capital or spare intellectual bandwidth to make the transformation to value-based care – and as many of you have told me, at the end of the day, you just want to see patients.

There are a lot of reasons to sit on the sidelines a while longer. I get it. But that indecision could result in the biggest decision of your career. But it won’t be your decision – it will be defaulted to others. Why?

Welcome to MACRA – the Medicare Access and CHIP Reauthorization Act. On April 16, 2015, President Obama signed sweeping legislation irrevocably moving the American health care system to value-based payment. The United States Senate and House – Republicans and Democrats – came together to replace the Sustainable Growth Rate formula (SGR) with MACRA.

MACRA represents the end of a long history of perpetually delayed Medicare physician fee schedule cuts that were to be automatically triggered under the punitive SGR formula absent Congress’ annual postponement ritual. After providing for a series of annual physician payment increases, MACRA’s reimbursement methodology transitions to a value-based model that includes two pathways: 1) the Alternative Payment Model (APM), and 2) the Merit-Based Incentive Payment System (MIPS).

APMs include organizations that are focused on providing high-quality and cost-effective care, while also taking on significant financial risk (for example, an ACO).

MACRA highly incentivizes provider participation in APMs. For example, APM participants will receive 5% bonus payments from 2019 to 2024, if they receive a certain percentage of their Medicare revenue through APMs. In addition, providers qualifying as APM participants are excluded from participating in the MIPS model and are subject only to their own quality standards.

Under the MIPS model, provider performance will be evaluated according to established performance standards and used to calculate an adjustment factor that will then determine a provider’s payment for the year.

The performance standards will include the following weighted categories: 1. quality, 2. resource use, 3. clinical practice improvement activities, and 4. meaningful use. Depending on their performance in these categories, providers will receive either a positive adjustment, no adjustment, or a negative adjustment.

In 2022, these adjustments will range from a 9% negative adjustment to a similar positive adjustment. MIPS will apply to all Medicare services and items provided on or after Jan. 1, 2019.

What does this mean to you?

You are going to be reimbursed as if you have embraced value-based population health management, whether you really do or not. The MIPS formula could deny you north of 9% of your payments. Conversely, if you decide to get into an ACO or something similar, you not only don’t get dinged, you receive a 5% bump in fee-for-service compensation and the chance for additional savings payments. Of course, you have to decide to actually engage and lead this care improvement from your medical home. A fake ACO that lets costs rise will be responsible for those increases.

Readers of this column know that the statistics are bearing out the fact that primary care–led ACOs are the best model. The whole premise has changed. Instead of paying for volume and expensive procedures for very sick people, it rewards value – that is the highest quality at the lowest costs – through things in primary care’s wheelhouse: prevention, wellness, care coordination, complex patient management, and medical home care transition management.

In fact, CMS has recognized this by making primary care subspecialties the only ones required to be in the Medicare ACO program and the Medicare Shared Savings Program (MSSP), and recently with its ACO Investment Model, which prioritized ACO advanced infrastructure payments to physician- or small hospital-led ACOs in rural areas.

There are more physician-owned ACOs today than any other kind. If you are part of another type of ACO, such as one driven by a health system or multispecialty practice, don’t despair. They can work, too. But you need to step up and make sure they do.

The price of passivity

MACRA’s shifting of the annual flow of $3 trillion from rewarding volume to rewarding value will, in this author’s estimation, have MACRA easily eclipse the Affordable Care Act in significance. Indecision will not stop your placement in the value-based payment system. Why not control your destiny to achieve your professional and financial goals as leaders of health care? Through indecision, you will be both unprepared and defaulted into the quality and efficiency compensation measurements of MIPS.

MACRA has changed everything. You’ve been asked to lead American health care and get paid to do it. This is not a hard question. Please feel free to contact me directly with questions or comments on how to prepare.

Mr. Bobbitt is a head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He is president of Value Health Partners, LLC, a health care strategic consulting company. He has years of experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author at [email protected] or 919-821-6612.

By now, most of us have heard of accountable care organizations and bundled payment. But for many of you, the shift to value-based population health management or compensation based on performance hasn’t affected your practice.

You still get paid fee for service. You’ve seen “the next big thing” in health care come and go; you don’t have the capital or spare intellectual bandwidth to make the transformation to value-based care – and as many of you have told me, at the end of the day, you just want to see patients.

There are a lot of reasons to sit on the sidelines a while longer. I get it. But that indecision could result in the biggest decision of your career. But it won’t be your decision – it will be defaulted to others. Why?

Welcome to MACRA – the Medicare Access and CHIP Reauthorization Act. On April 16, 2015, President Obama signed sweeping legislation irrevocably moving the American health care system to value-based payment. The United States Senate and House – Republicans and Democrats – came together to replace the Sustainable Growth Rate formula (SGR) with MACRA.

MACRA represents the end of a long history of perpetually delayed Medicare physician fee schedule cuts that were to be automatically triggered under the punitive SGR formula absent Congress’ annual postponement ritual. After providing for a series of annual physician payment increases, MACRA’s reimbursement methodology transitions to a value-based model that includes two pathways: 1) the Alternative Payment Model (APM), and 2) the Merit-Based Incentive Payment System (MIPS).

APMs include organizations that are focused on providing high-quality and cost-effective care, while also taking on significant financial risk (for example, an ACO).

MACRA highly incentivizes provider participation in APMs. For example, APM participants will receive 5% bonus payments from 2019 to 2024, if they receive a certain percentage of their Medicare revenue through APMs. In addition, providers qualifying as APM participants are excluded from participating in the MIPS model and are subject only to their own quality standards.

Under the MIPS model, provider performance will be evaluated according to established performance standards and used to calculate an adjustment factor that will then determine a provider’s payment for the year.

The performance standards will include the following weighted categories: 1. quality, 2. resource use, 3. clinical practice improvement activities, and 4. meaningful use. Depending on their performance in these categories, providers will receive either a positive adjustment, no adjustment, or a negative adjustment.

In 2022, these adjustments will range from a 9% negative adjustment to a similar positive adjustment. MIPS will apply to all Medicare services and items provided on or after Jan. 1, 2019.

What does this mean to you?

You are going to be reimbursed as if you have embraced value-based population health management, whether you really do or not. The MIPS formula could deny you north of 9% of your payments. Conversely, if you decide to get into an ACO or something similar, you not only don’t get dinged, you receive a 5% bump in fee-for-service compensation and the chance for additional savings payments. Of course, you have to decide to actually engage and lead this care improvement from your medical home. A fake ACO that lets costs rise will be responsible for those increases.

Readers of this column know that the statistics are bearing out the fact that primary care–led ACOs are the best model. The whole premise has changed. Instead of paying for volume and expensive procedures for very sick people, it rewards value – that is the highest quality at the lowest costs – through things in primary care’s wheelhouse: prevention, wellness, care coordination, complex patient management, and medical home care transition management.

In fact, CMS has recognized this by making primary care subspecialties the only ones required to be in the Medicare ACO program and the Medicare Shared Savings Program (MSSP), and recently with its ACO Investment Model, which prioritized ACO advanced infrastructure payments to physician- or small hospital-led ACOs in rural areas.

There are more physician-owned ACOs today than any other kind. If you are part of another type of ACO, such as one driven by a health system or multispecialty practice, don’t despair. They can work, too. But you need to step up and make sure they do.

The price of passivity

MACRA’s shifting of the annual flow of $3 trillion from rewarding volume to rewarding value will, in this author’s estimation, have MACRA easily eclipse the Affordable Care Act in significance. Indecision will not stop your placement in the value-based payment system. Why not control your destiny to achieve your professional and financial goals as leaders of health care? Through indecision, you will be both unprepared and defaulted into the quality and efficiency compensation measurements of MIPS.

MACRA has changed everything. You’ve been asked to lead American health care and get paid to do it. This is not a hard question. Please feel free to contact me directly with questions or comments on how to prepare.

Mr. Bobbitt is a head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He is president of Value Health Partners, LLC, a health care strategic consulting company. He has years of experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author at [email protected] or 919-821-6612.

By now, most of us have heard of accountable care organizations and bundled payment. But for many of you, the shift to value-based population health management or compensation based on performance hasn’t affected your practice.

You still get paid fee for service. You’ve seen “the next big thing” in health care come and go; you don’t have the capital or spare intellectual bandwidth to make the transformation to value-based care – and as many of you have told me, at the end of the day, you just want to see patients.

There are a lot of reasons to sit on the sidelines a while longer. I get it. But that indecision could result in the biggest decision of your career. But it won’t be your decision – it will be defaulted to others. Why?

Welcome to MACRA – the Medicare Access and CHIP Reauthorization Act. On April 16, 2015, President Obama signed sweeping legislation irrevocably moving the American health care system to value-based payment. The United States Senate and House – Republicans and Democrats – came together to replace the Sustainable Growth Rate formula (SGR) with MACRA.

MACRA represents the end of a long history of perpetually delayed Medicare physician fee schedule cuts that were to be automatically triggered under the punitive SGR formula absent Congress’ annual postponement ritual. After providing for a series of annual physician payment increases, MACRA’s reimbursement methodology transitions to a value-based model that includes two pathways: 1) the Alternative Payment Model (APM), and 2) the Merit-Based Incentive Payment System (MIPS).

APMs include organizations that are focused on providing high-quality and cost-effective care, while also taking on significant financial risk (for example, an ACO).

MACRA highly incentivizes provider participation in APMs. For example, APM participants will receive 5% bonus payments from 2019 to 2024, if they receive a certain percentage of their Medicare revenue through APMs. In addition, providers qualifying as APM participants are excluded from participating in the MIPS model and are subject only to their own quality standards.

Under the MIPS model, provider performance will be evaluated according to established performance standards and used to calculate an adjustment factor that will then determine a provider’s payment for the year.

The performance standards will include the following weighted categories: 1. quality, 2. resource use, 3. clinical practice improvement activities, and 4. meaningful use. Depending on their performance in these categories, providers will receive either a positive adjustment, no adjustment, or a negative adjustment.

In 2022, these adjustments will range from a 9% negative adjustment to a similar positive adjustment. MIPS will apply to all Medicare services and items provided on or after Jan. 1, 2019.

What does this mean to you?

You are going to be reimbursed as if you have embraced value-based population health management, whether you really do or not. The MIPS formula could deny you north of 9% of your payments. Conversely, if you decide to get into an ACO or something similar, you not only don’t get dinged, you receive a 5% bump in fee-for-service compensation and the chance for additional savings payments. Of course, you have to decide to actually engage and lead this care improvement from your medical home. A fake ACO that lets costs rise will be responsible for those increases.

Readers of this column know that the statistics are bearing out the fact that primary care–led ACOs are the best model. The whole premise has changed. Instead of paying for volume and expensive procedures for very sick people, it rewards value – that is the highest quality at the lowest costs – through things in primary care’s wheelhouse: prevention, wellness, care coordination, complex patient management, and medical home care transition management.

In fact, CMS has recognized this by making primary care subspecialties the only ones required to be in the Medicare ACO program and the Medicare Shared Savings Program (MSSP), and recently with its ACO Investment Model, which prioritized ACO advanced infrastructure payments to physician- or small hospital-led ACOs in rural areas.

There are more physician-owned ACOs today than any other kind. If you are part of another type of ACO, such as one driven by a health system or multispecialty practice, don’t despair. They can work, too. But you need to step up and make sure they do.

The price of passivity

MACRA’s shifting of the annual flow of $3 trillion from rewarding volume to rewarding value will, in this author’s estimation, have MACRA easily eclipse the Affordable Care Act in significance. Indecision will not stop your placement in the value-based payment system. Why not control your destiny to achieve your professional and financial goals as leaders of health care? Through indecision, you will be both unprepared and defaulted into the quality and efficiency compensation measurements of MIPS.

MACRA has changed everything. You’ve been asked to lead American health care and get paid to do it. This is not a hard question. Please feel free to contact me directly with questions or comments on how to prepare.

Mr. Bobbitt is a head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He is president of Value Health Partners, LLC, a health care strategic consulting company. He has years of experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author at [email protected] or 919-821-6612.

For things to see and do while at the Vascular Annual Meeting, consider National Harbor as a gateway port to Washington, D.C., situated just across the Potomac. The famous sights, monuments, museums, and cultural icons in the nation’s capitol are a given for any visitor (visit www.washington.org for a full rundown).

Olivier Le Queinec/ShutterStock

But there are also a lot of lesser known tourist attractions unavailable anywhere else in the country. Medical history buffs, for example, may want to visit the National Musuem of American History, which houses collections of medical science and biotechnology artifacts. And Civil War buffs with access to a car can visit the National Museum of Civil War Medicine in Frederick, Md., about an hour’s drive from National Harbor. Frederick was the site of three Confederate invasions and two major battles.

Cultural events abound during the annual meeting period. Theater goers can attend Shakespeare’s “Taming of the Shrew” or the musical “La Cage aux Folles.” You can attend the DC Jazz Festival or the National Symphony Orchestra’s performance of pieces by Bruckner and Mahler. For more cultural events, visit www.culturalcapitol.com.

For sports lovers, baseball season will be just getting underway and the Washington Nationals will be playing the Philadelphia Phillies on Saturday and Sunday at Nationals Park.

And National Harbor has its own attractions. Hardest to miss is the Capitol Wheel, a giant ferris wheel that soars 180 feet above the Potomac River waterfront, with views of the White House and Capitol, the National Mall, and all the surrounding DC metro area.

To plan your visit, check out www.nationalharbor.com/consumer/entertainment.

For things to see and do while at the Vascular Annual Meeting, consider National Harbor as a gateway port to Washington, D.C., situated just across the Potomac. The famous sights, monuments, museums, and cultural icons in the nation’s capitol are a given for any visitor (visit www.washington.org for a full rundown).

Olivier Le Queinec/ShutterStock

But there are also a lot of lesser known tourist attractions unavailable anywhere else in the country. Medical history buffs, for example, may want to visit the National Musuem of American History, which houses collections of medical science and biotechnology artifacts. And Civil War buffs with access to a car can visit the National Museum of Civil War Medicine in Frederick, Md., about an hour’s drive from National Harbor. Frederick was the site of three Confederate invasions and two major battles.

Cultural events abound during the annual meeting period. Theater goers can attend Shakespeare’s “Taming of the Shrew” or the musical “La Cage aux Folles.” You can attend the DC Jazz Festival or the National Symphony Orchestra’s performance of pieces by Bruckner and Mahler. For more cultural events, visit www.culturalcapitol.com.

For sports lovers, baseball season will be just getting underway and the Washington Nationals will be playing the Philadelphia Phillies on Saturday and Sunday at Nationals Park.

And National Harbor has its own attractions. Hardest to miss is the Capitol Wheel, a giant ferris wheel that soars 180 feet above the Potomac River waterfront, with views of the White House and Capitol, the National Mall, and all the surrounding DC metro area.

To plan your visit, check out www.nationalharbor.com/consumer/entertainment.

For things to see and do while at the Vascular Annual Meeting, consider National Harbor as a gateway port to Washington, D.C., situated just across the Potomac. The famous sights, monuments, museums, and cultural icons in the nation’s capitol are a given for any visitor (visit www.washington.org for a full rundown).

Olivier Le Queinec/ShutterStock

But there are also a lot of lesser known tourist attractions unavailable anywhere else in the country. Medical history buffs, for example, may want to visit the National Musuem of American History, which houses collections of medical science and biotechnology artifacts. And Civil War buffs with access to a car can visit the National Museum of Civil War Medicine in Frederick, Md., about an hour’s drive from National Harbor. Frederick was the site of three Confederate invasions and two major battles.

Cultural events abound during the annual meeting period. Theater goers can attend Shakespeare’s “Taming of the Shrew” or the musical “La Cage aux Folles.” You can attend the DC Jazz Festival or the National Symphony Orchestra’s performance of pieces by Bruckner and Mahler. For more cultural events, visit www.culturalcapitol.com.

For sports lovers, baseball season will be just getting underway and the Washington Nationals will be playing the Philadelphia Phillies on Saturday and Sunday at Nationals Park.

And National Harbor has its own attractions. Hardest to miss is the Capitol Wheel, a giant ferris wheel that soars 180 feet above the Potomac River waterfront, with views of the White House and Capitol, the National Mall, and all the surrounding DC metro area.

To plan your visit, check out www.nationalharbor.com/consumer/entertainment.

We are a product of our environment. But we shan’t forget that we are a product of the critical interaction between our environment and our evolutionary biology.

Back when we were roaming the plains searching for food, we likely experienced “forced fasts” (that is, we had no food). Our ancestors who were the best at surviving these periods of scarcity lived to bear us into our current period of staggering abundance. Now, we are the unhealthiest humans in history.

Is part of the answer to our current health problems to return to our roots and ... fast?

In a recent article by Catherine Marinac and her colleagues, patients aged 27-70 years with breast cancer in the Women’s Healthy Eating and Living study were analyzed to uncover the relationship between nightly fasting duration and new primary breast tumors and death (JAMA Oncol. 2016 Mar 31. doi: 10.1001/jamaoncol.2016.0164). Fasting was assessed through use of 24-hour dietary recall.

Fasting less than 13 hours per night was associated with an increased risk of breast cancer, compared with fasting at least 13 hours (hazard ratio, 1.36; 95% confidence interval, 1.05-1.76). Different fasting durations were not associated with breast cancer mortality.

Additional analyses demonstrated that each 2-hour increase in fasting duration was associated with significantly lower hemoglobin A_1c levels and a longer duration of nighttime sleep.

The positive health benefits of fasting have become increasingly “discussed,” albeit commonly on websites advertising for fasting cookbooks. Benefits of fasting include weight loss, improved insulin sensitivity, reductions in inflammation, improved cardiovascular risk factors, enhanced brain function, reductions in Alzheimer’s disease symptoms, and extended life span.

Many of these data are preliminary, and some are based upon animal models, such as the prolonged lifespan. In one study, rats undergoing alternate-day fasting lived 83% longer than rats who were not fasted. Interestingly, human data suggest that food consumption on the nonfasting days does not result in caloric consumption to cover the caloric deficit on the fasted day.

I have to admit that I am intrigued. I am not hearing much discussion about fasting among my colleagues – although a lot them skip meals, I know. But nobody is discussing it as a recommendation to appropriately selected patients (for example, not on insulin) to combat obesity and other diseases. I tried to suggest it to a patient the other day, who had a staggering amount of central adiposity, and he laughed at me. Is the thought of skipping eating for a day so anathema to our modern consumptive culture that we can’t even consider it?

Depending on the type of fasting that one is doing, one does not have to count calories on the fasting days, because there aren’t any. That makes it easy.

In a world of abundance and limitless food options, it may seem strange (self-indulgent?) to fast. But perhaps it will be a key to help us continue the species for a couple more generations.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

We are a product of our environment. But we shan’t forget that we are a product of the critical interaction between our environment and our evolutionary biology.

Back when we were roaming the plains searching for food, we likely experienced “forced fasts” (that is, we had no food). Our ancestors who were the best at surviving these periods of scarcity lived to bear us into our current period of staggering abundance. Now, we are the unhealthiest humans in history.

Is part of the answer to our current health problems to return to our roots and ... fast?

In a recent article by Catherine Marinac and her colleagues, patients aged 27-70 years with breast cancer in the Women’s Healthy Eating and Living study were analyzed to uncover the relationship between nightly fasting duration and new primary breast tumors and death (JAMA Oncol. 2016 Mar 31. doi: 10.1001/jamaoncol.2016.0164). Fasting was assessed through use of 24-hour dietary recall.

Fasting less than 13 hours per night was associated with an increased risk of breast cancer, compared with fasting at least 13 hours (hazard ratio, 1.36; 95% confidence interval, 1.05-1.76). Different fasting durations were not associated with breast cancer mortality.

Additional analyses demonstrated that each 2-hour increase in fasting duration was associated with significantly lower hemoglobin A_1c levels and a longer duration of nighttime sleep.

The positive health benefits of fasting have become increasingly “discussed,” albeit commonly on websites advertising for fasting cookbooks. Benefits of fasting include weight loss, improved insulin sensitivity, reductions in inflammation, improved cardiovascular risk factors, enhanced brain function, reductions in Alzheimer’s disease symptoms, and extended life span.

Many of these data are preliminary, and some are based upon animal models, such as the prolonged lifespan. In one study, rats undergoing alternate-day fasting lived 83% longer than rats who were not fasted. Interestingly, human data suggest that food consumption on the nonfasting days does not result in caloric consumption to cover the caloric deficit on the fasted day.

I have to admit that I am intrigued. I am not hearing much discussion about fasting among my colleagues – although a lot them skip meals, I know. But nobody is discussing it as a recommendation to appropriately selected patients (for example, not on insulin) to combat obesity and other diseases. I tried to suggest it to a patient the other day, who had a staggering amount of central adiposity, and he laughed at me. Is the thought of skipping eating for a day so anathema to our modern consumptive culture that we can’t even consider it?

Depending on the type of fasting that one is doing, one does not have to count calories on the fasting days, because there aren’t any. That makes it easy.

In a world of abundance and limitless food options, it may seem strange (self-indulgent?) to fast. But perhaps it will be a key to help us continue the species for a couple more generations.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

We are a product of our environment. But we shan’t forget that we are a product of the critical interaction between our environment and our evolutionary biology.

Back when we were roaming the plains searching for food, we likely experienced “forced fasts” (that is, we had no food). Our ancestors who were the best at surviving these periods of scarcity lived to bear us into our current period of staggering abundance. Now, we are the unhealthiest humans in history.

Is part of the answer to our current health problems to return to our roots and ... fast?

In a recent article by Catherine Marinac and her colleagues, patients aged 27-70 years with breast cancer in the Women’s Healthy Eating and Living study were analyzed to uncover the relationship between nightly fasting duration and new primary breast tumors and death (JAMA Oncol. 2016 Mar 31. doi: 10.1001/jamaoncol.2016.0164). Fasting was assessed through use of 24-hour dietary recall.

Fasting less than 13 hours per night was associated with an increased risk of breast cancer, compared with fasting at least 13 hours (hazard ratio, 1.36; 95% confidence interval, 1.05-1.76). Different fasting durations were not associated with breast cancer mortality.

Additional analyses demonstrated that each 2-hour increase in fasting duration was associated with significantly lower hemoglobin A_1c levels and a longer duration of nighttime sleep.

The positive health benefits of fasting have become increasingly “discussed,” albeit commonly on websites advertising for fasting cookbooks. Benefits of fasting include weight loss, improved insulin sensitivity, reductions in inflammation, improved cardiovascular risk factors, enhanced brain function, reductions in Alzheimer’s disease symptoms, and extended life span.

Many of these data are preliminary, and some are based upon animal models, such as the prolonged lifespan. In one study, rats undergoing alternate-day fasting lived 83% longer than rats who were not fasted. Interestingly, human data suggest that food consumption on the nonfasting days does not result in caloric consumption to cover the caloric deficit on the fasted day.

I have to admit that I am intrigued. I am not hearing much discussion about fasting among my colleagues – although a lot them skip meals, I know. But nobody is discussing it as a recommendation to appropriately selected patients (for example, not on insulin) to combat obesity and other diseases. I tried to suggest it to a patient the other day, who had a staggering amount of central adiposity, and he laughed at me. Is the thought of skipping eating for a day so anathema to our modern consumptive culture that we can’t even consider it?

Depending on the type of fasting that one is doing, one does not have to count calories on the fasting days, because there aren’t any. That makes it easy.

In a world of abundance and limitless food options, it may seem strange (self-indulgent?) to fast. But perhaps it will be a key to help us continue the species for a couple more generations.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.