Hospital Medicine 2016 Brims with Lively Talks, Record Crowds in San Diego

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Hospital Medicine 2016 Brims with Lively Talks, Record Crowds in San Diego

Yes, it rained some in dry San Diego—for the first time in a month, according to locals. But that was the extent of the disappointment at HM16—SHM’s annual meeting highlighted by inspiring words from the U.S. surgeon general, a fellow hospitalist.

Image Credit: Ania Rzepko

Read more about the speakers at HM16.

HM16 featured fascinating perspectives from giants in the field, vigorous panel discussions, lively workshops, streamlined how-to’s, encouraging work-life talks, and practical presentations on management.

And a record-breaking crowd continued the field’s trajectory of expansion.

“You were 4,000 strong this year,” said assistant course director Leonard Feldman, MD, SFHM. “Next year, let’s try for five.”

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Yes, it rained some in dry San Diego—for the first time in a month, according to locals. But that was the extent of the disappointment at HM16—SHM’s annual meeting highlighted by inspiring words from the U.S. surgeon general, a fellow hospitalist.

Image Credit: Ania Rzepko

Read more about the speakers at HM16.

HM16 featured fascinating perspectives from giants in the field, vigorous panel discussions, lively workshops, streamlined how-to’s, encouraging work-life talks, and practical presentations on management.

And a record-breaking crowd continued the field’s trajectory of expansion.

“You were 4,000 strong this year,” said assistant course director Leonard Feldman, MD, SFHM. “Next year, let’s try for five.”

Yes, it rained some in dry San Diego—for the first time in a month, according to locals. But that was the extent of the disappointment at HM16—SHM’s annual meeting highlighted by inspiring words from the U.S. surgeon general, a fellow hospitalist.

Image Credit: Ania Rzepko

Read more about the speakers at HM16.

HM16 featured fascinating perspectives from giants in the field, vigorous panel discussions, lively workshops, streamlined how-to’s, encouraging work-life talks, and practical presentations on management.

And a record-breaking crowd continued the field’s trajectory of expansion.

“You were 4,000 strong this year,” said assistant course director Leonard Feldman, MD, SFHM. “Next year, let’s try for five.”

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Community Partnerships, Data Key to Readmission Reduction in Diverse Populations

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Community Partnerships, Data Key to Readmission Reduction in Diverse Populations

When Houston Methodist Hospital noticed patients in one particular zip code were failing to make it to follow-up appointments after hospital discharge, they looked into it.

“We found it wasn’t on a bus route,” says Janice Finder, RN, MSN, director of the hospital’s Transitions in Care program and a part of SHM’s Project BOOST, which focuses on successful discharge outcomes. So in collaboration with the Texas Department of Aging and Disability Services, the hospital provided cab vouchers for these patients to travel to and from appointments.

The hospital also realized that to improve the chances its large Hispanic diabetic population remained healthy, it would need to tailor its disease management efforts to their culture, particularly when it came to diet.

“Their eating habits are very different, and we want to ensure they have meals based on what they actually eat,” Finder says.

These are exactly the kinds of approaches a new guide developed for the Centers for Medicare & Medicaid Services (CMS) by the Disparities Solutions Center (DSC), based at Massachusetts General Hospital (MGH) in Boston, is looking to promote in an effort to reduce unnecessary hospital readmissions.1 CMS recently made the Guide to Preventing Readmissions among Racially and Ethnically Diverse Medicare Beneficiaries available on its website.

Aswita Tan-McGrory, MBA, MSPH

“We know readmissions is an issue for diverse populations, that they are more likely than their white counterparts to be admitted within 30 days of discharge,” says Aswita Tan-McGrory, MBA, MSPH, deputy director of DSC within the Mongan Institute for Health Policy at MGH. “So there was a good business case for creating this guide.”

Keys to Success

Within the guide is a collection of evidence-based information, case studies, and seven recommendations the DSC team assembled to assist hospital leaders looking to reduce readmissions among some of the nation’s highest-risk populations.

While Tan-McGrory acknowledges it may be impractical for hospitals to adopt each recommendation, she says they can pick and choose which they can most effectively adopt.

“We put together these seven steps and looked for who does this really well, and the honest truth is not very many are,” she says. “It’s a complicated process, but it’s some guidance because there really wasn’t anything out there.”

Included in the recommendations: Create a “strong radar” (engage in robust data collection), identify root causes, begin to think about discharge at admission, deploy a team, consider systems and social determinants, focus on culturally competent communication, and foster community partnerships.

“It’s not just medication reconciliation or discharge instructions in a different language,” Tan-McGrory says. “What happens when a patient gets home?”

These types of questions are important because CMS now penalizes hospitals for what it deems excessive avoidable readmissions within 30 days of discharge. In 2016, hospitals can lose up to 3% of their Medicare payments under the Hospital Readmissions Reduction Program.

In 2014, nearly 18% of Medicare patients were admitted within a month of discharge at a cost of $26 billion.2 According to the new guide, Agency for Healthcare Research and Quality data indicate African-American and Hispanic patients make up a higher share of these readmissions, in part because they are disproportionately affected by chronic high-readmission-risk diseases like congestive heart failure.

Social Determinants

Though it’s challenging for healthcare providers, one way to reduce readmissions is to address the social determinants of health, Tan-McGrory says.

“Hospitals have felt in the past that it’s not their domain, but their patients are coming back,” she says. “How do you address people’s isolation at home? How can you send them from the hospital when no one is there to follow up or take care of them?”

 

 

The answers may lie in part on building community partnerships, something in which Finder’s hospital has successfully engaged. For example, the hospital has teamed with its local United Way to work with Asian patients on issues related to pain management and palliative care.

At Berkshire Medical Center, a 300-bed community teaching hospital in western Massachusetts, electronic health software helps staff flag patients at admission for potential readmission risks. Looking briefly at the new guide, William DeMarco, DO, SFHM, chief of hospital medicine (and also part of Project BOOST), noticed several new areas they may be able to incorporate into the system.

But adequate data collection and interpretation to help understand these disparities is not always possible, particularly for readmissions, Dr. DeMarco says.

However, as in one of the case studies examined in the DCS guide, Berkshire recently began to identify its high utilizers, pairing multidisciplinary teams with individual primary care providers in order to help meet these patients’ needs.

“It can take several hours for one patient, coordinating and getting a lot of people together,” Dr. DeMarco says. “It’s the only way to accomplish that goal, but it’s very resource intensive.”

Although hospitals traditionally focus on what they can do within their four walls, providers are becoming increasingly aware that the social determinants of health—like transportation, dietary choices, and language barriers—deeply impact some racial and ethnically diverse populations. Now, CMS thinks it’s worth paying closer attention. TH


Kelly April Tyrrell is a freelance writer in Madison, Wis.

References

  1. Betancourt JR, Tan-McGrory A, Kenst KS. Guide to preventing readmissions among racially and ethnically diverse medicare beneficiaries. Prepared by the Disparities Solutions Center, Mongan Institute for Health Policy at Massachusetts General Hospital. Baltimore, MD: Centers for Medicare & Medicaid Services Office of Minority Health; September 2015.
  2. Rau J. Medicare fines 2,610 hospitals in third round of readmission penalties. Kaiser Health News. Available at: http://kaiserhealthnews.org/news/medicare-readmissions-penalties-2015/. Accessed February 15, 2016.
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When Houston Methodist Hospital noticed patients in one particular zip code were failing to make it to follow-up appointments after hospital discharge, they looked into it.

“We found it wasn’t on a bus route,” says Janice Finder, RN, MSN, director of the hospital’s Transitions in Care program and a part of SHM’s Project BOOST, which focuses on successful discharge outcomes. So in collaboration with the Texas Department of Aging and Disability Services, the hospital provided cab vouchers for these patients to travel to and from appointments.

The hospital also realized that to improve the chances its large Hispanic diabetic population remained healthy, it would need to tailor its disease management efforts to their culture, particularly when it came to diet.

“Their eating habits are very different, and we want to ensure they have meals based on what they actually eat,” Finder says.

These are exactly the kinds of approaches a new guide developed for the Centers for Medicare & Medicaid Services (CMS) by the Disparities Solutions Center (DSC), based at Massachusetts General Hospital (MGH) in Boston, is looking to promote in an effort to reduce unnecessary hospital readmissions.1 CMS recently made the Guide to Preventing Readmissions among Racially and Ethnically Diverse Medicare Beneficiaries available on its website.

Aswita Tan-McGrory, MBA, MSPH

“We know readmissions is an issue for diverse populations, that they are more likely than their white counterparts to be admitted within 30 days of discharge,” says Aswita Tan-McGrory, MBA, MSPH, deputy director of DSC within the Mongan Institute for Health Policy at MGH. “So there was a good business case for creating this guide.”

Keys to Success

Within the guide is a collection of evidence-based information, case studies, and seven recommendations the DSC team assembled to assist hospital leaders looking to reduce readmissions among some of the nation’s highest-risk populations.

While Tan-McGrory acknowledges it may be impractical for hospitals to adopt each recommendation, she says they can pick and choose which they can most effectively adopt.

“We put together these seven steps and looked for who does this really well, and the honest truth is not very many are,” she says. “It’s a complicated process, but it’s some guidance because there really wasn’t anything out there.”

Included in the recommendations: Create a “strong radar” (engage in robust data collection), identify root causes, begin to think about discharge at admission, deploy a team, consider systems and social determinants, focus on culturally competent communication, and foster community partnerships.

“It’s not just medication reconciliation or discharge instructions in a different language,” Tan-McGrory says. “What happens when a patient gets home?”

These types of questions are important because CMS now penalizes hospitals for what it deems excessive avoidable readmissions within 30 days of discharge. In 2016, hospitals can lose up to 3% of their Medicare payments under the Hospital Readmissions Reduction Program.

In 2014, nearly 18% of Medicare patients were admitted within a month of discharge at a cost of $26 billion.2 According to the new guide, Agency for Healthcare Research and Quality data indicate African-American and Hispanic patients make up a higher share of these readmissions, in part because they are disproportionately affected by chronic high-readmission-risk diseases like congestive heart failure.

Social Determinants

Though it’s challenging for healthcare providers, one way to reduce readmissions is to address the social determinants of health, Tan-McGrory says.

“Hospitals have felt in the past that it’s not their domain, but their patients are coming back,” she says. “How do you address people’s isolation at home? How can you send them from the hospital when no one is there to follow up or take care of them?”

 

 

The answers may lie in part on building community partnerships, something in which Finder’s hospital has successfully engaged. For example, the hospital has teamed with its local United Way to work with Asian patients on issues related to pain management and palliative care.

At Berkshire Medical Center, a 300-bed community teaching hospital in western Massachusetts, electronic health software helps staff flag patients at admission for potential readmission risks. Looking briefly at the new guide, William DeMarco, DO, SFHM, chief of hospital medicine (and also part of Project BOOST), noticed several new areas they may be able to incorporate into the system.

But adequate data collection and interpretation to help understand these disparities is not always possible, particularly for readmissions, Dr. DeMarco says.

However, as in one of the case studies examined in the DCS guide, Berkshire recently began to identify its high utilizers, pairing multidisciplinary teams with individual primary care providers in order to help meet these patients’ needs.

“It can take several hours for one patient, coordinating and getting a lot of people together,” Dr. DeMarco says. “It’s the only way to accomplish that goal, but it’s very resource intensive.”

Although hospitals traditionally focus on what they can do within their four walls, providers are becoming increasingly aware that the social determinants of health—like transportation, dietary choices, and language barriers—deeply impact some racial and ethnically diverse populations. Now, CMS thinks it’s worth paying closer attention. TH


Kelly April Tyrrell is a freelance writer in Madison, Wis.

References

  1. Betancourt JR, Tan-McGrory A, Kenst KS. Guide to preventing readmissions among racially and ethnically diverse medicare beneficiaries. Prepared by the Disparities Solutions Center, Mongan Institute for Health Policy at Massachusetts General Hospital. Baltimore, MD: Centers for Medicare & Medicaid Services Office of Minority Health; September 2015.
  2. Rau J. Medicare fines 2,610 hospitals in third round of readmission penalties. Kaiser Health News. Available at: http://kaiserhealthnews.org/news/medicare-readmissions-penalties-2015/. Accessed February 15, 2016.

When Houston Methodist Hospital noticed patients in one particular zip code were failing to make it to follow-up appointments after hospital discharge, they looked into it.

“We found it wasn’t on a bus route,” says Janice Finder, RN, MSN, director of the hospital’s Transitions in Care program and a part of SHM’s Project BOOST, which focuses on successful discharge outcomes. So in collaboration with the Texas Department of Aging and Disability Services, the hospital provided cab vouchers for these patients to travel to and from appointments.

The hospital also realized that to improve the chances its large Hispanic diabetic population remained healthy, it would need to tailor its disease management efforts to their culture, particularly when it came to diet.

“Their eating habits are very different, and we want to ensure they have meals based on what they actually eat,” Finder says.

These are exactly the kinds of approaches a new guide developed for the Centers for Medicare & Medicaid Services (CMS) by the Disparities Solutions Center (DSC), based at Massachusetts General Hospital (MGH) in Boston, is looking to promote in an effort to reduce unnecessary hospital readmissions.1 CMS recently made the Guide to Preventing Readmissions among Racially and Ethnically Diverse Medicare Beneficiaries available on its website.

Aswita Tan-McGrory, MBA, MSPH

“We know readmissions is an issue for diverse populations, that they are more likely than their white counterparts to be admitted within 30 days of discharge,” says Aswita Tan-McGrory, MBA, MSPH, deputy director of DSC within the Mongan Institute for Health Policy at MGH. “So there was a good business case for creating this guide.”

Keys to Success

Within the guide is a collection of evidence-based information, case studies, and seven recommendations the DSC team assembled to assist hospital leaders looking to reduce readmissions among some of the nation’s highest-risk populations.

While Tan-McGrory acknowledges it may be impractical for hospitals to adopt each recommendation, she says they can pick and choose which they can most effectively adopt.

“We put together these seven steps and looked for who does this really well, and the honest truth is not very many are,” she says. “It’s a complicated process, but it’s some guidance because there really wasn’t anything out there.”

Included in the recommendations: Create a “strong radar” (engage in robust data collection), identify root causes, begin to think about discharge at admission, deploy a team, consider systems and social determinants, focus on culturally competent communication, and foster community partnerships.

“It’s not just medication reconciliation or discharge instructions in a different language,” Tan-McGrory says. “What happens when a patient gets home?”

These types of questions are important because CMS now penalizes hospitals for what it deems excessive avoidable readmissions within 30 days of discharge. In 2016, hospitals can lose up to 3% of their Medicare payments under the Hospital Readmissions Reduction Program.

In 2014, nearly 18% of Medicare patients were admitted within a month of discharge at a cost of $26 billion.2 According to the new guide, Agency for Healthcare Research and Quality data indicate African-American and Hispanic patients make up a higher share of these readmissions, in part because they are disproportionately affected by chronic high-readmission-risk diseases like congestive heart failure.

Social Determinants

Though it’s challenging for healthcare providers, one way to reduce readmissions is to address the social determinants of health, Tan-McGrory says.

“Hospitals have felt in the past that it’s not their domain, but their patients are coming back,” she says. “How do you address people’s isolation at home? How can you send them from the hospital when no one is there to follow up or take care of them?”

 

 

The answers may lie in part on building community partnerships, something in which Finder’s hospital has successfully engaged. For example, the hospital has teamed with its local United Way to work with Asian patients on issues related to pain management and palliative care.

At Berkshire Medical Center, a 300-bed community teaching hospital in western Massachusetts, electronic health software helps staff flag patients at admission for potential readmission risks. Looking briefly at the new guide, William DeMarco, DO, SFHM, chief of hospital medicine (and also part of Project BOOST), noticed several new areas they may be able to incorporate into the system.

But adequate data collection and interpretation to help understand these disparities is not always possible, particularly for readmissions, Dr. DeMarco says.

However, as in one of the case studies examined in the DCS guide, Berkshire recently began to identify its high utilizers, pairing multidisciplinary teams with individual primary care providers in order to help meet these patients’ needs.

“It can take several hours for one patient, coordinating and getting a lot of people together,” Dr. DeMarco says. “It’s the only way to accomplish that goal, but it’s very resource intensive.”

Although hospitals traditionally focus on what they can do within their four walls, providers are becoming increasingly aware that the social determinants of health—like transportation, dietary choices, and language barriers—deeply impact some racial and ethnically diverse populations. Now, CMS thinks it’s worth paying closer attention. TH


Kelly April Tyrrell is a freelance writer in Madison, Wis.

References

  1. Betancourt JR, Tan-McGrory A, Kenst KS. Guide to preventing readmissions among racially and ethnically diverse medicare beneficiaries. Prepared by the Disparities Solutions Center, Mongan Institute for Health Policy at Massachusetts General Hospital. Baltimore, MD: Centers for Medicare & Medicaid Services Office of Minority Health; September 2015.
  2. Rau J. Medicare fines 2,610 hospitals in third round of readmission penalties. Kaiser Health News. Available at: http://kaiserhealthnews.org/news/medicare-readmissions-penalties-2015/. Accessed February 15, 2016.
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'Everything We Say and Do': Soliciting Goals from Our Patients and Their Families

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'Everything We Say and Do': Soliciting Goals from Our Patients and Their Families

Editor’s note: “Everything We Say and Do” is an informational series developed by SHM’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experience of care. Each article will focus on how the contributor applies one ormore of the “key communication” tactics in practice to maintain provider accountability for “Everything we say and do that affects our patients’ thoughts, feelings and well-being.”

Read more from the “Everything We Say and Do” series.

What I Say and Do

Solicit a patient’s agenda and use active listening.

Why I Do It

The literature shows that, in most cases, doctors interrupt within 18 to 23 seconds and that when we interrupt, patients often never get back to what they were saying, the course of their story changes, and our diagnostic accuracy decreases. I also do it because I learn things that I wouldn’t otherwise know, and my patients feel heard and treated with respect. Listening has a healing effect, and in medicine, it can be equally if not more therapeutic than the medicines and clinical care we provide. I find that it helps me to be a more effective doctor, one who is helping my patient in the way that is most meaningful and helpful to them. It is very easy to navigate an encounter from the physician point of view and to make assumptions about what people want and need from me, but in reality, what is most important to me is not always what is most important to them.

Allowing patients to tell me what is important shows them respect and also sets me up for success as I am more likely to know and meet their needs. Doing this up front saves time by preventing the “doorknob” questions on the way out.  The human connection that follows keeps me connected to my purpose as a doctor. People often worry that listening will take too much time, but we know from the literature that most patients will talk for no more than 90 seconds. It’s really a very short amount of time for a gold mine of information.

How I Do It

Before I jump into my agenda, I make sure to know what is on the patient’s and family’s mind. What is most important to them to address? Once we have agreed on what we will be discussing or doing with our time in a way that includes both what I and the patient/family find important, I start by asking the patient to tell me everything about the first item at hand. I do not interrupt by asking questions, making comments, or “fixing.” I approach them with authentic curiosity, encouraging more without directing what they say.

I start with, “I’m here to talk to you about _____, but first, can you tell me what you’d like to make sure we talk about today?” Or, “Tell me a list of things that you’d like to make sure we talk about today.”

I follow that with, “What else?” until there is nothing else. Once we have negotiated what we will discuss, I say, “Tell me all about _______.” I do not interrupt or think about my response while I am listening. My only response is to use nonverbal continuers (“Uh huh,” “mmmm”), reflections (“That sounds really hard”), verbal continuers (“Tell me more”), empathic statements (“I can see why you would feel that way”), and body language that shows I am with them (sitting at eye level, facing them, looking at them rather than at my phone, pager or a computer screen.)

 

 

All of this happens before I jump into any of my own focused or clarifying questions.

Dr. Sliwka is medical director of patient and provider experience, medical director of the Goldman Medical Service, and associate clinical professor of medicine in the Division of Hospital Medicine at the UCSF Medical Center in San Francisco.

Table 1.

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Sections

Editor’s note: “Everything We Say and Do” is an informational series developed by SHM’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experience of care. Each article will focus on how the contributor applies one ormore of the “key communication” tactics in practice to maintain provider accountability for “Everything we say and do that affects our patients’ thoughts, feelings and well-being.”

Read more from the “Everything We Say and Do” series.

What I Say and Do

Solicit a patient’s agenda and use active listening.

Why I Do It

The literature shows that, in most cases, doctors interrupt within 18 to 23 seconds and that when we interrupt, patients often never get back to what they were saying, the course of their story changes, and our diagnostic accuracy decreases. I also do it because I learn things that I wouldn’t otherwise know, and my patients feel heard and treated with respect. Listening has a healing effect, and in medicine, it can be equally if not more therapeutic than the medicines and clinical care we provide. I find that it helps me to be a more effective doctor, one who is helping my patient in the way that is most meaningful and helpful to them. It is very easy to navigate an encounter from the physician point of view and to make assumptions about what people want and need from me, but in reality, what is most important to me is not always what is most important to them.

Allowing patients to tell me what is important shows them respect and also sets me up for success as I am more likely to know and meet their needs. Doing this up front saves time by preventing the “doorknob” questions on the way out.  The human connection that follows keeps me connected to my purpose as a doctor. People often worry that listening will take too much time, but we know from the literature that most patients will talk for no more than 90 seconds. It’s really a very short amount of time for a gold mine of information.

How I Do It

Before I jump into my agenda, I make sure to know what is on the patient’s and family’s mind. What is most important to them to address? Once we have agreed on what we will be discussing or doing with our time in a way that includes both what I and the patient/family find important, I start by asking the patient to tell me everything about the first item at hand. I do not interrupt by asking questions, making comments, or “fixing.” I approach them with authentic curiosity, encouraging more without directing what they say.

I start with, “I’m here to talk to you about _____, but first, can you tell me what you’d like to make sure we talk about today?” Or, “Tell me a list of things that you’d like to make sure we talk about today.”

I follow that with, “What else?” until there is nothing else. Once we have negotiated what we will discuss, I say, “Tell me all about _______.” I do not interrupt or think about my response while I am listening. My only response is to use nonverbal continuers (“Uh huh,” “mmmm”), reflections (“That sounds really hard”), verbal continuers (“Tell me more”), empathic statements (“I can see why you would feel that way”), and body language that shows I am with them (sitting at eye level, facing them, looking at them rather than at my phone, pager or a computer screen.)

 

 

All of this happens before I jump into any of my own focused or clarifying questions.

Dr. Sliwka is medical director of patient and provider experience, medical director of the Goldman Medical Service, and associate clinical professor of medicine in the Division of Hospital Medicine at the UCSF Medical Center in San Francisco.

Table 1.

Editor’s note: “Everything We Say and Do” is an informational series developed by SHM’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experience of care. Each article will focus on how the contributor applies one ormore of the “key communication” tactics in practice to maintain provider accountability for “Everything we say and do that affects our patients’ thoughts, feelings and well-being.”

Read more from the “Everything We Say and Do” series.

What I Say and Do

Solicit a patient’s agenda and use active listening.

Why I Do It

The literature shows that, in most cases, doctors interrupt within 18 to 23 seconds and that when we interrupt, patients often never get back to what they were saying, the course of their story changes, and our diagnostic accuracy decreases. I also do it because I learn things that I wouldn’t otherwise know, and my patients feel heard and treated with respect. Listening has a healing effect, and in medicine, it can be equally if not more therapeutic than the medicines and clinical care we provide. I find that it helps me to be a more effective doctor, one who is helping my patient in the way that is most meaningful and helpful to them. It is very easy to navigate an encounter from the physician point of view and to make assumptions about what people want and need from me, but in reality, what is most important to me is not always what is most important to them.

Allowing patients to tell me what is important shows them respect and also sets me up for success as I am more likely to know and meet their needs. Doing this up front saves time by preventing the “doorknob” questions on the way out.  The human connection that follows keeps me connected to my purpose as a doctor. People often worry that listening will take too much time, but we know from the literature that most patients will talk for no more than 90 seconds. It’s really a very short amount of time for a gold mine of information.

How I Do It

Before I jump into my agenda, I make sure to know what is on the patient’s and family’s mind. What is most important to them to address? Once we have agreed on what we will be discussing or doing with our time in a way that includes both what I and the patient/family find important, I start by asking the patient to tell me everything about the first item at hand. I do not interrupt by asking questions, making comments, or “fixing.” I approach them with authentic curiosity, encouraging more without directing what they say.

I start with, “I’m here to talk to you about _____, but first, can you tell me what you’d like to make sure we talk about today?” Or, “Tell me a list of things that you’d like to make sure we talk about today.”

I follow that with, “What else?” until there is nothing else. Once we have negotiated what we will discuss, I say, “Tell me all about _______.” I do not interrupt or think about my response while I am listening. My only response is to use nonverbal continuers (“Uh huh,” “mmmm”), reflections (“That sounds really hard”), verbal continuers (“Tell me more”), empathic statements (“I can see why you would feel that way”), and body language that shows I am with them (sitting at eye level, facing them, looking at them rather than at my phone, pager or a computer screen.)

 

 

All of this happens before I jump into any of my own focused or clarifying questions.

Dr. Sliwka is medical director of patient and provider experience, medical director of the Goldman Medical Service, and associate clinical professor of medicine in the Division of Hospital Medicine at the UCSF Medical Center in San Francisco.

Table 1.

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Study Suggests Growing Up in a Stress-Free Environment Lowers your Risk of Heart Attacks

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(Reuters Health) - Kids who live in a stress-free environment may grow up to be adults with a lower risk of heart attacks than their peers who experience social, emotional or financial difficulties during childhood, a Finnish study suggests.

Researchers assessed psychosocial factors in 311 kids at age 12 and 18. Then, at age 28, they looked for coronary artery calcification.

The adults who had high psychosocial wellbeing as kids were 15% less likely to have calcium deposits clogging their arteries as adults, the study found.

"This study suggests that childhood psychosocial factors may have long-term consequences on cardiovascular health," lead study author Dr. Markus Juonala of the University of Turku in Finland said by email.

To understand the connection between how kids feel growing up and how their arteries look decades later, Juonala and colleagues analyzed data gathered from 1980 to 2008 as part of the Cardiovascular Risk in Young Finns Study.

Among other things, this study measured psychosocial wellbeing by looking at family income and education levels, parents' job status, parents' mental health and history of smoking or substance abuse, parents' weight and exercise habits, stressful events such as divorce, death or moves, as well as the child's level of aggressive or anti-social behaviors and ability to interact with other people.

In addition, researchers analyzed results from computed tomography (CT) scans assessing coronary artery calcification. Overall, 55 participants, or about 18%, had at least some calcification in their arteries, researchers report in JAMA Pediatrics, March 14.

Among this group with calcification, 28 participants had low levels of buildup, 20 had moderate amounts of calcium and 7 had substantial deposits, the study found.

Even after accounting for adult circumstances like psychosocial factors and risk factors for heart disease like obesity, smoking, hypertension and elevated cholesterol, the research team still found well-being during childhood was associated with reduced coronary artery calcification in adulthood.

The study is observational and doesn't prove childhood stress causes clogged arteries or heart attacks, only that the two things are related, the authors note.

It's possible, however, that stress during childhood might trigger changes in metabolic functioning and inflammation that later contribute to calcium deposits in the arteries, the researchers point out.

It's also possible that happier kids may develop healthier habits like better diets and more rigorous exercise routines that help keep arteries unclogged and lower their risk of heart disease later in life.

"The take-home message for parents is to understand that stress in childhood may have many adverse effects and that they should help their children avoid stress," said Dr. Stephen Daniels, a researcher at the University of Colorado School of Medicine and pediatrician-in-chief at Children's Hospital Colorado.

Parents may not always be able to eliminate stress, however, particularly the stress that can come from environmental factors like lower socioeconomic status, Daniels, who wasn't involved in the study, added by email.

When children grow up with stress, they can still take charge of their health as adults to lower their risk of heart disease, Daniels noted.

"For an adult who had a stressful childhood, the best approach is to be aware of their cardiovascular risk status and to reduce their risk by improving diet and physical activity and avoiding cigarette smoking," Daniels added. "Where risk factors exist, such as high blood pressure, they should be appropriately treated."

 

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(Reuters Health) - Kids who live in a stress-free environment may grow up to be adults with a lower risk of heart attacks than their peers who experience social, emotional or financial difficulties during childhood, a Finnish study suggests.

Researchers assessed psychosocial factors in 311 kids at age 12 and 18. Then, at age 28, they looked for coronary artery calcification.

The adults who had high psychosocial wellbeing as kids were 15% less likely to have calcium deposits clogging their arteries as adults, the study found.

"This study suggests that childhood psychosocial factors may have long-term consequences on cardiovascular health," lead study author Dr. Markus Juonala of the University of Turku in Finland said by email.

To understand the connection between how kids feel growing up and how their arteries look decades later, Juonala and colleagues analyzed data gathered from 1980 to 2008 as part of the Cardiovascular Risk in Young Finns Study.

Among other things, this study measured psychosocial wellbeing by looking at family income and education levels, parents' job status, parents' mental health and history of smoking or substance abuse, parents' weight and exercise habits, stressful events such as divorce, death or moves, as well as the child's level of aggressive or anti-social behaviors and ability to interact with other people.

In addition, researchers analyzed results from computed tomography (CT) scans assessing coronary artery calcification. Overall, 55 participants, or about 18%, had at least some calcification in their arteries, researchers report in JAMA Pediatrics, March 14.

Among this group with calcification, 28 participants had low levels of buildup, 20 had moderate amounts of calcium and 7 had substantial deposits, the study found.

Even after accounting for adult circumstances like psychosocial factors and risk factors for heart disease like obesity, smoking, hypertension and elevated cholesterol, the research team still found well-being during childhood was associated with reduced coronary artery calcification in adulthood.

The study is observational and doesn't prove childhood stress causes clogged arteries or heart attacks, only that the two things are related, the authors note.

It's possible, however, that stress during childhood might trigger changes in metabolic functioning and inflammation that later contribute to calcium deposits in the arteries, the researchers point out.

It's also possible that happier kids may develop healthier habits like better diets and more rigorous exercise routines that help keep arteries unclogged and lower their risk of heart disease later in life.

"The take-home message for parents is to understand that stress in childhood may have many adverse effects and that they should help their children avoid stress," said Dr. Stephen Daniels, a researcher at the University of Colorado School of Medicine and pediatrician-in-chief at Children's Hospital Colorado.

Parents may not always be able to eliminate stress, however, particularly the stress that can come from environmental factors like lower socioeconomic status, Daniels, who wasn't involved in the study, added by email.

When children grow up with stress, they can still take charge of their health as adults to lower their risk of heart disease, Daniels noted.

"For an adult who had a stressful childhood, the best approach is to be aware of their cardiovascular risk status and to reduce their risk by improving diet and physical activity and avoiding cigarette smoking," Daniels added. "Where risk factors exist, such as high blood pressure, they should be appropriately treated."

 

(Reuters Health) - Kids who live in a stress-free environment may grow up to be adults with a lower risk of heart attacks than their peers who experience social, emotional or financial difficulties during childhood, a Finnish study suggests.

Researchers assessed psychosocial factors in 311 kids at age 12 and 18. Then, at age 28, they looked for coronary artery calcification.

The adults who had high psychosocial wellbeing as kids were 15% less likely to have calcium deposits clogging their arteries as adults, the study found.

"This study suggests that childhood psychosocial factors may have long-term consequences on cardiovascular health," lead study author Dr. Markus Juonala of the University of Turku in Finland said by email.

To understand the connection between how kids feel growing up and how their arteries look decades later, Juonala and colleagues analyzed data gathered from 1980 to 2008 as part of the Cardiovascular Risk in Young Finns Study.

Among other things, this study measured psychosocial wellbeing by looking at family income and education levels, parents' job status, parents' mental health and history of smoking or substance abuse, parents' weight and exercise habits, stressful events such as divorce, death or moves, as well as the child's level of aggressive or anti-social behaviors and ability to interact with other people.

In addition, researchers analyzed results from computed tomography (CT) scans assessing coronary artery calcification. Overall, 55 participants, or about 18%, had at least some calcification in their arteries, researchers report in JAMA Pediatrics, March 14.

Among this group with calcification, 28 participants had low levels of buildup, 20 had moderate amounts of calcium and 7 had substantial deposits, the study found.

Even after accounting for adult circumstances like psychosocial factors and risk factors for heart disease like obesity, smoking, hypertension and elevated cholesterol, the research team still found well-being during childhood was associated with reduced coronary artery calcification in adulthood.

The study is observational and doesn't prove childhood stress causes clogged arteries or heart attacks, only that the two things are related, the authors note.

It's possible, however, that stress during childhood might trigger changes in metabolic functioning and inflammation that later contribute to calcium deposits in the arteries, the researchers point out.

It's also possible that happier kids may develop healthier habits like better diets and more rigorous exercise routines that help keep arteries unclogged and lower their risk of heart disease later in life.

"The take-home message for parents is to understand that stress in childhood may have many adverse effects and that they should help their children avoid stress," said Dr. Stephen Daniels, a researcher at the University of Colorado School of Medicine and pediatrician-in-chief at Children's Hospital Colorado.

Parents may not always be able to eliminate stress, however, particularly the stress that can come from environmental factors like lower socioeconomic status, Daniels, who wasn't involved in the study, added by email.

When children grow up with stress, they can still take charge of their health as adults to lower their risk of heart disease, Daniels noted.

"For an adult who had a stressful childhood, the best approach is to be aware of their cardiovascular risk status and to reduce their risk by improving diet and physical activity and avoiding cigarette smoking," Daniels added. "Where risk factors exist, such as high blood pressure, they should be appropriately treated."

 

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Studies explain how mutations promote lymphoma

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Diffuse large B-cell lymphoma

New research suggests there are 4 different “locks” that keep the CARD11 protein in check.

Researchers say these locks, also known as “repressive elements,” work together to prevent unwarranted CARD11 signaling.

But mutations in CARD11 can perturb or bypass the action of the repressive elements, which leads to a level of hyperactive CARD11 signaling that supports lymphoma growth.

Joel Pomerantz, PhD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland, and his colleagues reported these findings in 2 articles published in The Journal of Biological Chemistry.1,2

The researchers noted that mutated CARD11 proteins are sometimes found in patients with lymphoma, particularly diffuse large B-cell lymphoma. But none of the mutations exist in the “lock region” of CARD11, known as the autoinhibitory domain.

To find out why, the team conducted experiments with T cells. They first genetically deleted CARD11’s autoinhibitory domain so that the protein was always “on” and signaling.

Then, to figure out which region of the autoinhibitory domain accounted for its function, the researchers systematically deleted 6 different segments of it one at a time, rather than deleting the whole thing.

They expected most of the deletions to keep CARD11 inactive and 1 or 2 to “unlock” it. However, none of the deletions unlocked it, which suggested there was more than 1 repressive element within the autoinhibitory domain.

To see if that was the case and to find out how many repressive elements there might be, the researchers deleted the full autoinhibitory domain again, then added back small regions of it.

In this way, they pieced together the presence of 4 different biochemical regions, or repressive elements, that are each capable of locking CARD11 on their own.

“Having 4 redundant repressive elements seems to explain why patients with lymphoma don’t have mutations in CARD11’s autoinhibitory domain,” Dr Pomerantz said. “A mutation in any one of the repressive elements would only unlock 1 of the 4 locks, keeping CARD11’s signaling under the control of the other 3.”

So where do the lymphoma-associated mutations occur, and how do they circumvent CARD11’s quadruple locks? Clinical data show that the mutations occur in 3 other regions of CARD11—the CARD, LATCH, and coiled-coil regions.

Dr Pomerantz and his colleagues conducted biochemical tests on T cells and found that those 3 regions clasp the autoinhibitory domain to keep CARD11’s activity on lockdown. This makes sense, Dr Pomerantz said, because CARD11 uses those same regions to connect with other signaling proteins to send its message.

“When they are interacting with the autoinhibitory domain, they can’t be interacting with other proteins,” he said.

According to Dr Pomerantz, single mutations in the CARD, LATCH, or coiled-coil regions appear to be sufficient to disable the 4 repressive elements. And the ultimate goal is to advance the development of therapies that rein in hyperactive CARD11 in patients with lymphoma.

“If we can understand how CARD11 is normally kept off, we might be able to mimic that with a drug,” he said. “We also hope to shed light on how different mutations in CARD11 affect its function and a patient’s prognosis.”

1. Cooperative Control of Caspase Recruitment Domain-Containing Protein 11 (CARD11) Signaling by an Unusual Array of Redundant Repressive Elements

2. Intramolecular Interactions and Regulation of Cofactor Binding by the Four Repressive Elements in the Caspase Recruitment Domain-Containing Protein 11 (CARD11) Inhibitory Domain

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Diffuse large B-cell lymphoma

New research suggests there are 4 different “locks” that keep the CARD11 protein in check.

Researchers say these locks, also known as “repressive elements,” work together to prevent unwarranted CARD11 signaling.

But mutations in CARD11 can perturb or bypass the action of the repressive elements, which leads to a level of hyperactive CARD11 signaling that supports lymphoma growth.

Joel Pomerantz, PhD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland, and his colleagues reported these findings in 2 articles published in The Journal of Biological Chemistry.1,2

The researchers noted that mutated CARD11 proteins are sometimes found in patients with lymphoma, particularly diffuse large B-cell lymphoma. But none of the mutations exist in the “lock region” of CARD11, known as the autoinhibitory domain.

To find out why, the team conducted experiments with T cells. They first genetically deleted CARD11’s autoinhibitory domain so that the protein was always “on” and signaling.

Then, to figure out which region of the autoinhibitory domain accounted for its function, the researchers systematically deleted 6 different segments of it one at a time, rather than deleting the whole thing.

They expected most of the deletions to keep CARD11 inactive and 1 or 2 to “unlock” it. However, none of the deletions unlocked it, which suggested there was more than 1 repressive element within the autoinhibitory domain.

To see if that was the case and to find out how many repressive elements there might be, the researchers deleted the full autoinhibitory domain again, then added back small regions of it.

In this way, they pieced together the presence of 4 different biochemical regions, or repressive elements, that are each capable of locking CARD11 on their own.

“Having 4 redundant repressive elements seems to explain why patients with lymphoma don’t have mutations in CARD11’s autoinhibitory domain,” Dr Pomerantz said. “A mutation in any one of the repressive elements would only unlock 1 of the 4 locks, keeping CARD11’s signaling under the control of the other 3.”

So where do the lymphoma-associated mutations occur, and how do they circumvent CARD11’s quadruple locks? Clinical data show that the mutations occur in 3 other regions of CARD11—the CARD, LATCH, and coiled-coil regions.

Dr Pomerantz and his colleagues conducted biochemical tests on T cells and found that those 3 regions clasp the autoinhibitory domain to keep CARD11’s activity on lockdown. This makes sense, Dr Pomerantz said, because CARD11 uses those same regions to connect with other signaling proteins to send its message.

“When they are interacting with the autoinhibitory domain, they can’t be interacting with other proteins,” he said.

According to Dr Pomerantz, single mutations in the CARD, LATCH, or coiled-coil regions appear to be sufficient to disable the 4 repressive elements. And the ultimate goal is to advance the development of therapies that rein in hyperactive CARD11 in patients with lymphoma.

“If we can understand how CARD11 is normally kept off, we might be able to mimic that with a drug,” he said. “We also hope to shed light on how different mutations in CARD11 affect its function and a patient’s prognosis.”

1. Cooperative Control of Caspase Recruitment Domain-Containing Protein 11 (CARD11) Signaling by an Unusual Array of Redundant Repressive Elements

2. Intramolecular Interactions and Regulation of Cofactor Binding by the Four Repressive Elements in the Caspase Recruitment Domain-Containing Protein 11 (CARD11) Inhibitory Domain

Diffuse large B-cell lymphoma

New research suggests there are 4 different “locks” that keep the CARD11 protein in check.

Researchers say these locks, also known as “repressive elements,” work together to prevent unwarranted CARD11 signaling.

But mutations in CARD11 can perturb or bypass the action of the repressive elements, which leads to a level of hyperactive CARD11 signaling that supports lymphoma growth.

Joel Pomerantz, PhD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland, and his colleagues reported these findings in 2 articles published in The Journal of Biological Chemistry.1,2

The researchers noted that mutated CARD11 proteins are sometimes found in patients with lymphoma, particularly diffuse large B-cell lymphoma. But none of the mutations exist in the “lock region” of CARD11, known as the autoinhibitory domain.

To find out why, the team conducted experiments with T cells. They first genetically deleted CARD11’s autoinhibitory domain so that the protein was always “on” and signaling.

Then, to figure out which region of the autoinhibitory domain accounted for its function, the researchers systematically deleted 6 different segments of it one at a time, rather than deleting the whole thing.

They expected most of the deletions to keep CARD11 inactive and 1 or 2 to “unlock” it. However, none of the deletions unlocked it, which suggested there was more than 1 repressive element within the autoinhibitory domain.

To see if that was the case and to find out how many repressive elements there might be, the researchers deleted the full autoinhibitory domain again, then added back small regions of it.

In this way, they pieced together the presence of 4 different biochemical regions, or repressive elements, that are each capable of locking CARD11 on their own.

“Having 4 redundant repressive elements seems to explain why patients with lymphoma don’t have mutations in CARD11’s autoinhibitory domain,” Dr Pomerantz said. “A mutation in any one of the repressive elements would only unlock 1 of the 4 locks, keeping CARD11’s signaling under the control of the other 3.”

So where do the lymphoma-associated mutations occur, and how do they circumvent CARD11’s quadruple locks? Clinical data show that the mutations occur in 3 other regions of CARD11—the CARD, LATCH, and coiled-coil regions.

Dr Pomerantz and his colleagues conducted biochemical tests on T cells and found that those 3 regions clasp the autoinhibitory domain to keep CARD11’s activity on lockdown. This makes sense, Dr Pomerantz said, because CARD11 uses those same regions to connect with other signaling proteins to send its message.

“When they are interacting with the autoinhibitory domain, they can’t be interacting with other proteins,” he said.

According to Dr Pomerantz, single mutations in the CARD, LATCH, or coiled-coil regions appear to be sufficient to disable the 4 repressive elements. And the ultimate goal is to advance the development of therapies that rein in hyperactive CARD11 in patients with lymphoma.

“If we can understand how CARD11 is normally kept off, we might be able to mimic that with a drug,” he said. “We also hope to shed light on how different mutations in CARD11 affect its function and a patient’s prognosis.”

1. Cooperative Control of Caspase Recruitment Domain-Containing Protein 11 (CARD11) Signaling by an Unusual Array of Redundant Repressive Elements

2. Intramolecular Interactions and Regulation of Cofactor Binding by the Four Repressive Elements in the Caspase Recruitment Domain-Containing Protein 11 (CARD11) Inhibitory Domain

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Survey reveals HSCT trends in Europe

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HSCT preparation

Photo by Chad McNeeley

Results from the 2014 Transplant Activity Survey suggest the use of hematopoietic stem cell transplant (HSCT) is still on the rise in Europe.

The European Society for Blood and Marrow Transplantation (EBMT) introduced this survey in 1990 to assess the use of HSCT in Europe.

Every year, all EBMT members and affiliated teams report their number of transplant patients by indication, donor type, and stem cell source.

Results from the 2014 survey revealed that 40,829 HSCTs were conducted in 36,469 patients at 656 centers in 47 countries. Fifty-seven percent of these transplants were autologous (n=20,704), and 43% were allogeneic (n=15,765).

When compared to data from the 2013 survey, the total number of transplants increased by 4.1%—4.5% for allogeneic HSCT and 3.8% for autologous HSCT.

The greatest increases in allogeneic HSCT occurred in Romania, Russia, Turkey, Croatia, Lithuania, and Serbia. And the greatest increases for autologous HSCT occurred in Romania, Serbia, Russia, Turkey, and Iran.

The most common indication for HSCT in 2014 was lymphoid neoplasias (57%, n=20,802), followed by leukemias (33%, n=11,853), non-malignant disorders (6%, n=2203), and solid tumors (4%, n=1458).

Compared to data from 2013, there was an increase in allogeneic HSCT for a few indications. There was a 13% increase in allogeneic HSCT for acute myeloid leukemia in first complete remission, a 14% increase for myeloproliferative neoplasms, and a 12% increase for severe aplastic anemia.

For autologous HSCT, there was a 21% decrease for chronic lymphocytic leukemia, a 5% increase for myeloma, a 44% increase for amyloidosis, an 8% increase for Hodgkin lymphoma, and a 40% increase for autoimmune diseases.

For more details, see the full report in Bone Marrow Transplantation.

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HSCT preparation

Photo by Chad McNeeley

Results from the 2014 Transplant Activity Survey suggest the use of hematopoietic stem cell transplant (HSCT) is still on the rise in Europe.

The European Society for Blood and Marrow Transplantation (EBMT) introduced this survey in 1990 to assess the use of HSCT in Europe.

Every year, all EBMT members and affiliated teams report their number of transplant patients by indication, donor type, and stem cell source.

Results from the 2014 survey revealed that 40,829 HSCTs were conducted in 36,469 patients at 656 centers in 47 countries. Fifty-seven percent of these transplants were autologous (n=20,704), and 43% were allogeneic (n=15,765).

When compared to data from the 2013 survey, the total number of transplants increased by 4.1%—4.5% for allogeneic HSCT and 3.8% for autologous HSCT.

The greatest increases in allogeneic HSCT occurred in Romania, Russia, Turkey, Croatia, Lithuania, and Serbia. And the greatest increases for autologous HSCT occurred in Romania, Serbia, Russia, Turkey, and Iran.

The most common indication for HSCT in 2014 was lymphoid neoplasias (57%, n=20,802), followed by leukemias (33%, n=11,853), non-malignant disorders (6%, n=2203), and solid tumors (4%, n=1458).

Compared to data from 2013, there was an increase in allogeneic HSCT for a few indications. There was a 13% increase in allogeneic HSCT for acute myeloid leukemia in first complete remission, a 14% increase for myeloproliferative neoplasms, and a 12% increase for severe aplastic anemia.

For autologous HSCT, there was a 21% decrease for chronic lymphocytic leukemia, a 5% increase for myeloma, a 44% increase for amyloidosis, an 8% increase for Hodgkin lymphoma, and a 40% increase for autoimmune diseases.

For more details, see the full report in Bone Marrow Transplantation.

HSCT preparation

Photo by Chad McNeeley

Results from the 2014 Transplant Activity Survey suggest the use of hematopoietic stem cell transplant (HSCT) is still on the rise in Europe.

The European Society for Blood and Marrow Transplantation (EBMT) introduced this survey in 1990 to assess the use of HSCT in Europe.

Every year, all EBMT members and affiliated teams report their number of transplant patients by indication, donor type, and stem cell source.

Results from the 2014 survey revealed that 40,829 HSCTs were conducted in 36,469 patients at 656 centers in 47 countries. Fifty-seven percent of these transplants were autologous (n=20,704), and 43% were allogeneic (n=15,765).

When compared to data from the 2013 survey, the total number of transplants increased by 4.1%—4.5% for allogeneic HSCT and 3.8% for autologous HSCT.

The greatest increases in allogeneic HSCT occurred in Romania, Russia, Turkey, Croatia, Lithuania, and Serbia. And the greatest increases for autologous HSCT occurred in Romania, Serbia, Russia, Turkey, and Iran.

The most common indication for HSCT in 2014 was lymphoid neoplasias (57%, n=20,802), followed by leukemias (33%, n=11,853), non-malignant disorders (6%, n=2203), and solid tumors (4%, n=1458).

Compared to data from 2013, there was an increase in allogeneic HSCT for a few indications. There was a 13% increase in allogeneic HSCT for acute myeloid leukemia in first complete remission, a 14% increase for myeloproliferative neoplasms, and a 12% increase for severe aplastic anemia.

For autologous HSCT, there was a 21% decrease for chronic lymphocytic leukemia, a 5% increase for myeloma, a 44% increase for amyloidosis, an 8% increase for Hodgkin lymphoma, and a 40% increase for autoimmune diseases.

For more details, see the full report in Bone Marrow Transplantation.

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Use of dangerous drug combos on the rise

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Use of dangerous drug combos on the rise

Patient consults pharmacist

Photo by Rhoda Baer

A new study suggests that older adults in the US may be using potentially deadly combinations of prescription drugs, over-the-counter medications, and dietary supplements.

Investigators observed a significant increase in the proportion of adults ages 62 to 85 who were at risk of major drug-drug interactions—from 8% in 2005-2006 to 15% in 2010-2011.

Most of the combinations consisted of preventative cardiovascular medications such as antiplatelet drugs, statins, and omega-3 fish oil supplements.

Dima Mazen Qato, PharmD, of the University of Illinois at Chicago, and her colleagues reported these results in JAMA Internal Medicine.

The investigators examined changes in medication use in a nationally representative sample of adults between the ages of 62 and 85. The team conducted in-home interviews to accurately identify medications. They interviewed 2351 subjects in 2005-2006 and 2206 subjects in 2010-2011.

The results showed a significant increase in the proportion of subjects taking at least 1 prescription medication—from 84.1% in 2005-2006 to 87.7% in 2010-2011 (P=0.003).

The proportion of subjects taking at least 5 prescription medications rose significantly as well—from 30.6% to 35.8% (P=0.02).

The investigators said factors that may account for these increases include the implementation of Medicare Part D, changes in treatment guidelines, and the increased availability of generics for many commonly used drugs.

As an example, use of the statin simvastatin (Zocor)—which became available as a generic in 2006—rose from 10.3% in 2005-2006 to 22.5% in 2010-2011.

The use of over-the-counter medications declined from 44.4% in 2005-2006 to 37.9% in 2010-2011 (P<0.001), while the use of dietary supplements increased from 51.8% to 63.7% (P<0.001).

Drug-drug interactions

The investigators identified 15 potentially life-threatening combinations of the most commonly used medications and supplements in the study.

They found that 15.1% of subjects were at risk for a potential major drug-drug interaction in 2010-2011, compared with an estimated 8.4% in 2005-2006 (P<0.001).

Dr Qato noted that more than half of the potential interactions involved a nonprescription medication or dietary supplement.

Preventative cardiovascular medications such as statins (particularly, simvastatin), antiplatelet drugs (such as clopidogrel and aspirin), and supplements (specifically, omega-3 fish oil) accounted for the vast majority of these combinations.

“Many older patients seeking to improve their cardiovascular health are also regularly using interacting drug combinations that may worsen cardiovascular risk,” Dr Qato said.

“For example, the use of clopidogrel in combination with the proton-pump inhibitor omeprazole, aspirin, or naproxen—all over-the-counter medications—is associated with an increased risk of heart attacks, bleeding complications, or death. However, about 1.8%—or 1 million—older adults regularly use clopidogrel in interacting combinations.”

Dr Qato added that healthcare professionals should consider the adverse effects of commonly used prescription and nonprescription medication combinations when treating older adults and counsel patients about the risks.

“Improving safety in the use of interacting medication combinations has the potential to reduce preventable, potentially fatal, adverse drug events,” she said.

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Patient consults pharmacist

Photo by Rhoda Baer

A new study suggests that older adults in the US may be using potentially deadly combinations of prescription drugs, over-the-counter medications, and dietary supplements.

Investigators observed a significant increase in the proportion of adults ages 62 to 85 who were at risk of major drug-drug interactions—from 8% in 2005-2006 to 15% in 2010-2011.

Most of the combinations consisted of preventative cardiovascular medications such as antiplatelet drugs, statins, and omega-3 fish oil supplements.

Dima Mazen Qato, PharmD, of the University of Illinois at Chicago, and her colleagues reported these results in JAMA Internal Medicine.

The investigators examined changes in medication use in a nationally representative sample of adults between the ages of 62 and 85. The team conducted in-home interviews to accurately identify medications. They interviewed 2351 subjects in 2005-2006 and 2206 subjects in 2010-2011.

The results showed a significant increase in the proportion of subjects taking at least 1 prescription medication—from 84.1% in 2005-2006 to 87.7% in 2010-2011 (P=0.003).

The proportion of subjects taking at least 5 prescription medications rose significantly as well—from 30.6% to 35.8% (P=0.02).

The investigators said factors that may account for these increases include the implementation of Medicare Part D, changes in treatment guidelines, and the increased availability of generics for many commonly used drugs.

As an example, use of the statin simvastatin (Zocor)—which became available as a generic in 2006—rose from 10.3% in 2005-2006 to 22.5% in 2010-2011.

The use of over-the-counter medications declined from 44.4% in 2005-2006 to 37.9% in 2010-2011 (P<0.001), while the use of dietary supplements increased from 51.8% to 63.7% (P<0.001).

Drug-drug interactions

The investigators identified 15 potentially life-threatening combinations of the most commonly used medications and supplements in the study.

They found that 15.1% of subjects were at risk for a potential major drug-drug interaction in 2010-2011, compared with an estimated 8.4% in 2005-2006 (P<0.001).

Dr Qato noted that more than half of the potential interactions involved a nonprescription medication or dietary supplement.

Preventative cardiovascular medications such as statins (particularly, simvastatin), antiplatelet drugs (such as clopidogrel and aspirin), and supplements (specifically, omega-3 fish oil) accounted for the vast majority of these combinations.

“Many older patients seeking to improve their cardiovascular health are also regularly using interacting drug combinations that may worsen cardiovascular risk,” Dr Qato said.

“For example, the use of clopidogrel in combination with the proton-pump inhibitor omeprazole, aspirin, or naproxen—all over-the-counter medications—is associated with an increased risk of heart attacks, bleeding complications, or death. However, about 1.8%—or 1 million—older adults regularly use clopidogrel in interacting combinations.”

Dr Qato added that healthcare professionals should consider the adverse effects of commonly used prescription and nonprescription medication combinations when treating older adults and counsel patients about the risks.

“Improving safety in the use of interacting medication combinations has the potential to reduce preventable, potentially fatal, adverse drug events,” she said.

Patient consults pharmacist

Photo by Rhoda Baer

A new study suggests that older adults in the US may be using potentially deadly combinations of prescription drugs, over-the-counter medications, and dietary supplements.

Investigators observed a significant increase in the proportion of adults ages 62 to 85 who were at risk of major drug-drug interactions—from 8% in 2005-2006 to 15% in 2010-2011.

Most of the combinations consisted of preventative cardiovascular medications such as antiplatelet drugs, statins, and omega-3 fish oil supplements.

Dima Mazen Qato, PharmD, of the University of Illinois at Chicago, and her colleagues reported these results in JAMA Internal Medicine.

The investigators examined changes in medication use in a nationally representative sample of adults between the ages of 62 and 85. The team conducted in-home interviews to accurately identify medications. They interviewed 2351 subjects in 2005-2006 and 2206 subjects in 2010-2011.

The results showed a significant increase in the proportion of subjects taking at least 1 prescription medication—from 84.1% in 2005-2006 to 87.7% in 2010-2011 (P=0.003).

The proportion of subjects taking at least 5 prescription medications rose significantly as well—from 30.6% to 35.8% (P=0.02).

The investigators said factors that may account for these increases include the implementation of Medicare Part D, changes in treatment guidelines, and the increased availability of generics for many commonly used drugs.

As an example, use of the statin simvastatin (Zocor)—which became available as a generic in 2006—rose from 10.3% in 2005-2006 to 22.5% in 2010-2011.

The use of over-the-counter medications declined from 44.4% in 2005-2006 to 37.9% in 2010-2011 (P<0.001), while the use of dietary supplements increased from 51.8% to 63.7% (P<0.001).

Drug-drug interactions

The investigators identified 15 potentially life-threatening combinations of the most commonly used medications and supplements in the study.

They found that 15.1% of subjects were at risk for a potential major drug-drug interaction in 2010-2011, compared with an estimated 8.4% in 2005-2006 (P<0.001).

Dr Qato noted that more than half of the potential interactions involved a nonprescription medication or dietary supplement.

Preventative cardiovascular medications such as statins (particularly, simvastatin), antiplatelet drugs (such as clopidogrel and aspirin), and supplements (specifically, omega-3 fish oil) accounted for the vast majority of these combinations.

“Many older patients seeking to improve their cardiovascular health are also regularly using interacting drug combinations that may worsen cardiovascular risk,” Dr Qato said.

“For example, the use of clopidogrel in combination with the proton-pump inhibitor omeprazole, aspirin, or naproxen—all over-the-counter medications—is associated with an increased risk of heart attacks, bleeding complications, or death. However, about 1.8%—or 1 million—older adults regularly use clopidogrel in interacting combinations.”

Dr Qato added that healthcare professionals should consider the adverse effects of commonly used prescription and nonprescription medication combinations when treating older adults and counsel patients about the risks.

“Improving safety in the use of interacting medication combinations has the potential to reduce preventable, potentially fatal, adverse drug events,” she said.

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ROCK2 inhibitor treats chronic GVHD in mice

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ROCK2 inhibitor treats chronic GVHD in mice

Lab mouse

Preclinical data suggest that blocking the Rho-associated coiled-coil kinase 2 (ROCK2) signaling pathway with the ROCK2 inhibitor KD025 can ameliorate chronic graft-versus-host disease (cGVHD).

Previous studies have shown that IL-21 and IL-17, 2 pro-inflammatory cytokines regulated by the ROCK2 signaling pathway, play a key role in cGVHD pathogenesis.

In the new study, targeted ROCK2 inhibition with KD025 had a therapeutic effect on cGVHD cytokines and signaling pathways involved in the pathogenesis of cGVHD.

Bruce R. Blazar, MD, of the University of Minnesota in Minneapolis, and his colleagues reported these findings in Blood.

The research was supported by Kadmon Corporation, LLC, the company developing KD025, as well as other sources.

The researchers found that KD025 reversed the clinical and immunological symptoms of cGVHD in 2 murine models: a full major histocompatibility complex (MHC)-mismatch model of multi-organ system cGVHD with bronchiolitis obliterans syndrome and a minor MHC-mismatch model of sclerodermatous GVHD.

Mice treated with KD025 showed improvements in pulmonary function and had a significant decrease in cGVHD pathology in the lung, liver, and spleen, when compared to vehicle-treated animals.

In addition, KD025 treatment did not affect the graft-versus-leukemia effect or immune response to viral pathogens.

In both animal models, KD025 treatment downregulated phosphorylation of STAT3, a pro-inflammatory signaling pathway that plays a key role in the development of cGVHD.

In human cells, KD025 inhibited the production of IL-21, IL-17, and IFN-γ. The drug also decreased STAT3 activity.

In both murine and human cells, KD025 downregulated STAT3 phosphorylation and simultaneously upregulated STAT5 phosphorylation, thereby reducing cGVHD progression.

“These data demonstrate that ROCK2 inhibition decreases cGVHD manifestation in murine and human models, which correlates with a demonstrated effect on molecular signaling pathways responsible for cGVHD pathogenesis,” Dr Blazar said.

Based on these results, Kadmon is planning to initiate a phase 2 study of KD025 for the treatment of cGVHD in mid-2016. The drug has already been tested in phase 1 studies of healthy volunteers.

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Lab mouse

Preclinical data suggest that blocking the Rho-associated coiled-coil kinase 2 (ROCK2) signaling pathway with the ROCK2 inhibitor KD025 can ameliorate chronic graft-versus-host disease (cGVHD).

Previous studies have shown that IL-21 and IL-17, 2 pro-inflammatory cytokines regulated by the ROCK2 signaling pathway, play a key role in cGVHD pathogenesis.

In the new study, targeted ROCK2 inhibition with KD025 had a therapeutic effect on cGVHD cytokines and signaling pathways involved in the pathogenesis of cGVHD.

Bruce R. Blazar, MD, of the University of Minnesota in Minneapolis, and his colleagues reported these findings in Blood.

The research was supported by Kadmon Corporation, LLC, the company developing KD025, as well as other sources.

The researchers found that KD025 reversed the clinical and immunological symptoms of cGVHD in 2 murine models: a full major histocompatibility complex (MHC)-mismatch model of multi-organ system cGVHD with bronchiolitis obliterans syndrome and a minor MHC-mismatch model of sclerodermatous GVHD.

Mice treated with KD025 showed improvements in pulmonary function and had a significant decrease in cGVHD pathology in the lung, liver, and spleen, when compared to vehicle-treated animals.

In addition, KD025 treatment did not affect the graft-versus-leukemia effect or immune response to viral pathogens.

In both animal models, KD025 treatment downregulated phosphorylation of STAT3, a pro-inflammatory signaling pathway that plays a key role in the development of cGVHD.

In human cells, KD025 inhibited the production of IL-21, IL-17, and IFN-γ. The drug also decreased STAT3 activity.

In both murine and human cells, KD025 downregulated STAT3 phosphorylation and simultaneously upregulated STAT5 phosphorylation, thereby reducing cGVHD progression.

“These data demonstrate that ROCK2 inhibition decreases cGVHD manifestation in murine and human models, which correlates with a demonstrated effect on molecular signaling pathways responsible for cGVHD pathogenesis,” Dr Blazar said.

Based on these results, Kadmon is planning to initiate a phase 2 study of KD025 for the treatment of cGVHD in mid-2016. The drug has already been tested in phase 1 studies of healthy volunteers.

Lab mouse

Preclinical data suggest that blocking the Rho-associated coiled-coil kinase 2 (ROCK2) signaling pathway with the ROCK2 inhibitor KD025 can ameliorate chronic graft-versus-host disease (cGVHD).

Previous studies have shown that IL-21 and IL-17, 2 pro-inflammatory cytokines regulated by the ROCK2 signaling pathway, play a key role in cGVHD pathogenesis.

In the new study, targeted ROCK2 inhibition with KD025 had a therapeutic effect on cGVHD cytokines and signaling pathways involved in the pathogenesis of cGVHD.

Bruce R. Blazar, MD, of the University of Minnesota in Minneapolis, and his colleagues reported these findings in Blood.

The research was supported by Kadmon Corporation, LLC, the company developing KD025, as well as other sources.

The researchers found that KD025 reversed the clinical and immunological symptoms of cGVHD in 2 murine models: a full major histocompatibility complex (MHC)-mismatch model of multi-organ system cGVHD with bronchiolitis obliterans syndrome and a minor MHC-mismatch model of sclerodermatous GVHD.

Mice treated with KD025 showed improvements in pulmonary function and had a significant decrease in cGVHD pathology in the lung, liver, and spleen, when compared to vehicle-treated animals.

In addition, KD025 treatment did not affect the graft-versus-leukemia effect or immune response to viral pathogens.

In both animal models, KD025 treatment downregulated phosphorylation of STAT3, a pro-inflammatory signaling pathway that plays a key role in the development of cGVHD.

In human cells, KD025 inhibited the production of IL-21, IL-17, and IFN-γ. The drug also decreased STAT3 activity.

In both murine and human cells, KD025 downregulated STAT3 phosphorylation and simultaneously upregulated STAT5 phosphorylation, thereby reducing cGVHD progression.

“These data demonstrate that ROCK2 inhibition decreases cGVHD manifestation in murine and human models, which correlates with a demonstrated effect on molecular signaling pathways responsible for cGVHD pathogenesis,” Dr Blazar said.

Based on these results, Kadmon is planning to initiate a phase 2 study of KD025 for the treatment of cGVHD in mid-2016. The drug has already been tested in phase 1 studies of healthy volunteers.

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Ixekizumab approved for plaque psoriasis

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Ixekizumab is approved to treat moderate to severe plaque psoriasis in adults, according to an announcement from the Food and Drug Administration.

“Today’s approval provides patients suffering from plaque psoriasis with another important treatment option to help relieve the skin irritation and discomfort from the condition,” Dr. Julie Beitz, director of the FDA’s Office of Drug Evaluation III, said in a statement .

Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokines, inhibiting interaction with the IL-17 receptor. It is approved for patients who are candidates for systemic therapy, phototherapy, or a combination of both.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

The safety and efficacy of ixekizumab were established in three randomized, placebo-controlled clinical trials with a total of 3,866 participants with plaque psoriasis who were candidates for systemic therapy or phototherapy. Patients treated with ixekizumab achieved greater clinical response than did those who received placebo.

The therapy was approved with a medication guide to inform patients that they may have a greater risk of an infection, or an allergic or autoimmune condition, according to the FDA announcement. The agency advised that physicians should monitor patient for serious allergic reactions and development or worsening of inflammatory bowel disease.

The most common adverse events seen in clinical trials of ixekizumab were upper respiratory infections, injection site reactions, and tinea.

Ixekizumab will be marketed as Taltz by Eli Lilly and Company.

[email protected]

On Twitter @denisefulton

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Ixekizumab is approved to treat moderate to severe plaque psoriasis in adults, according to an announcement from the Food and Drug Administration.

“Today’s approval provides patients suffering from plaque psoriasis with another important treatment option to help relieve the skin irritation and discomfort from the condition,” Dr. Julie Beitz, director of the FDA’s Office of Drug Evaluation III, said in a statement .

Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokines, inhibiting interaction with the IL-17 receptor. It is approved for patients who are candidates for systemic therapy, phototherapy, or a combination of both.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

The safety and efficacy of ixekizumab were established in three randomized, placebo-controlled clinical trials with a total of 3,866 participants with plaque psoriasis who were candidates for systemic therapy or phototherapy. Patients treated with ixekizumab achieved greater clinical response than did those who received placebo.

The therapy was approved with a medication guide to inform patients that they may have a greater risk of an infection, or an allergic or autoimmune condition, according to the FDA announcement. The agency advised that physicians should monitor patient for serious allergic reactions and development or worsening of inflammatory bowel disease.

The most common adverse events seen in clinical trials of ixekizumab were upper respiratory infections, injection site reactions, and tinea.

Ixekizumab will be marketed as Taltz by Eli Lilly and Company.

[email protected]

On Twitter @denisefulton

Ixekizumab is approved to treat moderate to severe plaque psoriasis in adults, according to an announcement from the Food and Drug Administration.

“Today’s approval provides patients suffering from plaque psoriasis with another important treatment option to help relieve the skin irritation and discomfort from the condition,” Dr. Julie Beitz, director of the FDA’s Office of Drug Evaluation III, said in a statement .

Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokines, inhibiting interaction with the IL-17 receptor. It is approved for patients who are candidates for systemic therapy, phototherapy, or a combination of both.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

The safety and efficacy of ixekizumab were established in three randomized, placebo-controlled clinical trials with a total of 3,866 participants with plaque psoriasis who were candidates for systemic therapy or phototherapy. Patients treated with ixekizumab achieved greater clinical response than did those who received placebo.

The therapy was approved with a medication guide to inform patients that they may have a greater risk of an infection, or an allergic or autoimmune condition, according to the FDA announcement. The agency advised that physicians should monitor patient for serious allergic reactions and development or worsening of inflammatory bowel disease.

The most common adverse events seen in clinical trials of ixekizumab were upper respiratory infections, injection site reactions, and tinea.

Ixekizumab will be marketed as Taltz by Eli Lilly and Company.

[email protected]

On Twitter @denisefulton

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Pushback on Part B drug payment proposal already beginning

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Pushback on Part B drug payment proposal already beginning

Rheumatologists already are voicing concerns regarding a new proposal to test adjustments to how drugs administered in a physician’s office are paid for.

That proposal, published March 11 in the Federal Register, would test a change to the current reimbursement of average sales price plus 6% for Part B drugs with a lower add-on percentage of 2.5% plus $16.50.

Dr. Norman B. Gaylis

In a fact sheet highlighting the proposals, the Centers for Medicare & Medicaid Services said the change to a lower percentage plus a flat fee “will cover the cost of any drug paid under Medicare Part B.”

However, there are already questions about that.

“While this may seem the way in which CMS will control costs, they fail to recognize the cost to facilities in obtaining approval for these treatments, receiving and storing, and ultimately safely administering these therapies in an environment that provides the best outcomes for patients,” Dr. Norman B. Gaylis, a rheumatologist in private practice in Aventura, Fla., said.

In fact, Dr. Gaylis adds that the focus on lowering drug expenses in the Part B space could have the unintended consequence of raising these expenses because it will force a change of venue.

“It has become so prohibitive that ultimately many patients will be referred to more expensive, less efficient outpatient facilities with, in fact, an increase in overall costs,” he said.

More than 300 provider and patient groups covering a range of specialties and including the American College of Rheumatology, the Coalition of State Rheumatology Organizations, and a number of state rheumatology organizations, are calling on Congress to ask CMS to withdraw the proposal.

In a March 17 letter to the majority and minority leaders in both chambers, the group is challenging the CMS assertion in the proposed rule that the current 6% add-on “may encourage the use of more expensive drugs because the 6% add-on generates more revenues for more expensive drugs.”

“This assumption fails to take into account the fact that providers’ prescribing decisions depend on a variety of factors, including clinical characteristics and the complex needs of the Medicare population,” the letter states. “Most importantly, there is no evidence indicating that the payment changes contemplated by the model will improve quality of care, and may adversely impact those patients that lose access to their most appropriate treatments.”

CMS offered two other pricing models that would be tested: indications-based pricing and reference pricing. The former would set payment rates based on the clinical effectiveness of a drug, while the latter would test the impact of setting a benchmark price for a group of drugs in a similar therapeutic class. Related to that is a proposal that CMS enter into voluntary risk-sharing agreements with drug manufacturers to link outcomes with price adjustments.

Dr. Gaylis suggested that CMS is going after the wrong party if cost containment is the ultimate goal here and should be focusing its efforts on the prices of the drugs themselves rather than how much they spend on physician reimbursement.

“Ironically, the major expense, i.e., the cost of drugs themselves, continues to spiral in the absence of any legitimate mechanism between CMS and pharma to contract prices that could save health care billions of dollars,” he said. “Ultimately, in my opinion, the solution rests in creating a fair and equal price for facilities administering these therapies and creating a pass-through where the drugs are not part of the physician’s risk, cost, or benefit and all payers, including CMS, can negotiate drug costs directly with the manufacturer.”

As part of the proposed rule, CMS also is considering creating feedback and decision-support tools to help, such as offering best practices for prescribing certain medications or providing feedback on prescribing patterns relative to local, regional, and national trends.

On the patient side, CMS is proposing to eliminate any patient cost sharing for office-administered drugs.

Comments on the proposals are due May 9.

[email protected]

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Rheumatologists already are voicing concerns regarding a new proposal to test adjustments to how drugs administered in a physician’s office are paid for.

That proposal, published March 11 in the Federal Register, would test a change to the current reimbursement of average sales price plus 6% for Part B drugs with a lower add-on percentage of 2.5% plus $16.50.

Dr. Norman B. Gaylis

In a fact sheet highlighting the proposals, the Centers for Medicare & Medicaid Services said the change to a lower percentage plus a flat fee “will cover the cost of any drug paid under Medicare Part B.”

However, there are already questions about that.

“While this may seem the way in which CMS will control costs, they fail to recognize the cost to facilities in obtaining approval for these treatments, receiving and storing, and ultimately safely administering these therapies in an environment that provides the best outcomes for patients,” Dr. Norman B. Gaylis, a rheumatologist in private practice in Aventura, Fla., said.

In fact, Dr. Gaylis adds that the focus on lowering drug expenses in the Part B space could have the unintended consequence of raising these expenses because it will force a change of venue.

“It has become so prohibitive that ultimately many patients will be referred to more expensive, less efficient outpatient facilities with, in fact, an increase in overall costs,” he said.

More than 300 provider and patient groups covering a range of specialties and including the American College of Rheumatology, the Coalition of State Rheumatology Organizations, and a number of state rheumatology organizations, are calling on Congress to ask CMS to withdraw the proposal.

In a March 17 letter to the majority and minority leaders in both chambers, the group is challenging the CMS assertion in the proposed rule that the current 6% add-on “may encourage the use of more expensive drugs because the 6% add-on generates more revenues for more expensive drugs.”

“This assumption fails to take into account the fact that providers’ prescribing decisions depend on a variety of factors, including clinical characteristics and the complex needs of the Medicare population,” the letter states. “Most importantly, there is no evidence indicating that the payment changes contemplated by the model will improve quality of care, and may adversely impact those patients that lose access to their most appropriate treatments.”

CMS offered two other pricing models that would be tested: indications-based pricing and reference pricing. The former would set payment rates based on the clinical effectiveness of a drug, while the latter would test the impact of setting a benchmark price for a group of drugs in a similar therapeutic class. Related to that is a proposal that CMS enter into voluntary risk-sharing agreements with drug manufacturers to link outcomes with price adjustments.

Dr. Gaylis suggested that CMS is going after the wrong party if cost containment is the ultimate goal here and should be focusing its efforts on the prices of the drugs themselves rather than how much they spend on physician reimbursement.

“Ironically, the major expense, i.e., the cost of drugs themselves, continues to spiral in the absence of any legitimate mechanism between CMS and pharma to contract prices that could save health care billions of dollars,” he said. “Ultimately, in my opinion, the solution rests in creating a fair and equal price for facilities administering these therapies and creating a pass-through where the drugs are not part of the physician’s risk, cost, or benefit and all payers, including CMS, can negotiate drug costs directly with the manufacturer.”

As part of the proposed rule, CMS also is considering creating feedback and decision-support tools to help, such as offering best practices for prescribing certain medications or providing feedback on prescribing patterns relative to local, regional, and national trends.

On the patient side, CMS is proposing to eliminate any patient cost sharing for office-administered drugs.

Comments on the proposals are due May 9.

[email protected]

Rheumatologists already are voicing concerns regarding a new proposal to test adjustments to how drugs administered in a physician’s office are paid for.

That proposal, published March 11 in the Federal Register, would test a change to the current reimbursement of average sales price plus 6% for Part B drugs with a lower add-on percentage of 2.5% plus $16.50.

Dr. Norman B. Gaylis

In a fact sheet highlighting the proposals, the Centers for Medicare & Medicaid Services said the change to a lower percentage plus a flat fee “will cover the cost of any drug paid under Medicare Part B.”

However, there are already questions about that.

“While this may seem the way in which CMS will control costs, they fail to recognize the cost to facilities in obtaining approval for these treatments, receiving and storing, and ultimately safely administering these therapies in an environment that provides the best outcomes for patients,” Dr. Norman B. Gaylis, a rheumatologist in private practice in Aventura, Fla., said.

In fact, Dr. Gaylis adds that the focus on lowering drug expenses in the Part B space could have the unintended consequence of raising these expenses because it will force a change of venue.

“It has become so prohibitive that ultimately many patients will be referred to more expensive, less efficient outpatient facilities with, in fact, an increase in overall costs,” he said.

More than 300 provider and patient groups covering a range of specialties and including the American College of Rheumatology, the Coalition of State Rheumatology Organizations, and a number of state rheumatology organizations, are calling on Congress to ask CMS to withdraw the proposal.

In a March 17 letter to the majority and minority leaders in both chambers, the group is challenging the CMS assertion in the proposed rule that the current 6% add-on “may encourage the use of more expensive drugs because the 6% add-on generates more revenues for more expensive drugs.”

“This assumption fails to take into account the fact that providers’ prescribing decisions depend on a variety of factors, including clinical characteristics and the complex needs of the Medicare population,” the letter states. “Most importantly, there is no evidence indicating that the payment changes contemplated by the model will improve quality of care, and may adversely impact those patients that lose access to their most appropriate treatments.”

CMS offered two other pricing models that would be tested: indications-based pricing and reference pricing. The former would set payment rates based on the clinical effectiveness of a drug, while the latter would test the impact of setting a benchmark price for a group of drugs in a similar therapeutic class. Related to that is a proposal that CMS enter into voluntary risk-sharing agreements with drug manufacturers to link outcomes with price adjustments.

Dr. Gaylis suggested that CMS is going after the wrong party if cost containment is the ultimate goal here and should be focusing its efforts on the prices of the drugs themselves rather than how much they spend on physician reimbursement.

“Ironically, the major expense, i.e., the cost of drugs themselves, continues to spiral in the absence of any legitimate mechanism between CMS and pharma to contract prices that could save health care billions of dollars,” he said. “Ultimately, in my opinion, the solution rests in creating a fair and equal price for facilities administering these therapies and creating a pass-through where the drugs are not part of the physician’s risk, cost, or benefit and all payers, including CMS, can negotiate drug costs directly with the manufacturer.”

As part of the proposed rule, CMS also is considering creating feedback and decision-support tools to help, such as offering best practices for prescribing certain medications or providing feedback on prescribing patterns relative to local, regional, and national trends.

On the patient side, CMS is proposing to eliminate any patient cost sharing for office-administered drugs.

Comments on the proposals are due May 9.

[email protected]

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