In this month's issue, our special report on the patient experience includes Dr. Jairy Hunter talking about things that impact the patient experience on the ward; Dr. Nasim Afsar discusses on how her love of science was sparked; and we feature the latest in HM clinical literature.

[audio mp3="http://www.the-hospitalist.org/wp-content/uploads/2015/09/September-2015-Hospitalist-Highlights.mp3"][/audio]

In this month's issue, our special report on the patient experience includes Dr. Jairy Hunter talking about things that impact the patient experience on the ward; Dr. Nasim Afsar discusses on how her love of science was sparked; and we feature the latest in HM clinical literature.

[audio mp3="http://www.the-hospitalist.org/wp-content/uploads/2015/09/September-2015-Hospitalist-Highlights.mp3"][/audio]

In this month's issue, our special report on the patient experience includes Dr. Jairy Hunter talking about things that impact the patient experience on the ward; Dr. Nasim Afsar discusses on how her love of science was sparked; and we feature the latest in HM clinical literature.

[audio mp3="http://www.the-hospitalist.org/wp-content/uploads/2015/09/September-2015-Hospitalist-Highlights.mp3"][/audio]

Clinical question: Does a short, fixed duration of antibiotic therapy for complicated intraabdominal infections lead to equivalent outcomes and less antibiotic exposure than the traditional approach?

Background: Published guidelines recommend appropriate antimicrobial agents for intraabdominal infections, but the optimal duration of therapy remains unclear. Most practitioners continue to treat for 10-14 days and until all physiologic evidence of the systemic inflammatory response syndrome (SIRS) has resolved. More recently, small studies have suggested that a shorter course may lead to equivalent outcomes with decreased antibiotic exposure.

Study design: Open-label, multicenter, randomized control trial.

Setting: Twenty-three sites throughout the U.S. and Canada.

Synopsis: In the short-course group, 257 patients were randomized to receive antimicrobial therapy for four full days after their index source-control procedure; 260 patients in the control group received antimicrobial therapy until two days after resolution of the physiological abnormalities related to SIRS. The median duration of therapy was 4.0 days (interquartile range [IQR], 4.0-5.0) for the experimental group and 8.0 days (IQR 5.0-10.0) in the control group (95% CI, -4.7 to -3.3; P<0.001).

There was no significant difference in surgical site infection, recurrent intraabdominal infection, or death between the experimental and control groups (21.8% vs. 22.3%, 95% CI -7.0 to 8.0; P=0.92). In the experimental group, 47 patients did not adhere to the protocol, all of whom received a longer antimicrobial treatment course than specified in the protocol.

This trial excluded patients without adequate source control and included a small number of immunocompromised hosts. The rate of nonadherence to the protocol was high, at 18% of patients in the experimental group. The calculated sample size to assert equivalence between groups was not achieved, although the results are suggestive of equivalence.

Bottom line: A shorter course of antimicrobial therapy for complicated intraabdominal infections might lead to equivalent outcomes with less antibiotic exposure compared with current practice; however, it is challenging for providers to stop antimicrobial therapy while patients continue to show physiologic evidence of SIRS.

Citation: Sawyer RG, Claridge JA, Nathens AB, et al. Trial of short-course antimicrobial therapy for intraabdominal infection. NEJM. 2015;372(21):1996-2005.

Clinical question: Does a short, fixed duration of antibiotic therapy for complicated intraabdominal infections lead to equivalent outcomes and less antibiotic exposure than the traditional approach?

Background: Published guidelines recommend appropriate antimicrobial agents for intraabdominal infections, but the optimal duration of therapy remains unclear. Most practitioners continue to treat for 10-14 days and until all physiologic evidence of the systemic inflammatory response syndrome (SIRS) has resolved. More recently, small studies have suggested that a shorter course may lead to equivalent outcomes with decreased antibiotic exposure.

Study design: Open-label, multicenter, randomized control trial.

Setting: Twenty-three sites throughout the U.S. and Canada.

Synopsis: In the short-course group, 257 patients were randomized to receive antimicrobial therapy for four full days after their index source-control procedure; 260 patients in the control group received antimicrobial therapy until two days after resolution of the physiological abnormalities related to SIRS. The median duration of therapy was 4.0 days (interquartile range [IQR], 4.0-5.0) for the experimental group and 8.0 days (IQR 5.0-10.0) in the control group (95% CI, -4.7 to -3.3; P<0.001).

There was no significant difference in surgical site infection, recurrent intraabdominal infection, or death between the experimental and control groups (21.8% vs. 22.3%, 95% CI -7.0 to 8.0; P=0.92). In the experimental group, 47 patients did not adhere to the protocol, all of whom received a longer antimicrobial treatment course than specified in the protocol.

This trial excluded patients without adequate source control and included a small number of immunocompromised hosts. The rate of nonadherence to the protocol was high, at 18% of patients in the experimental group. The calculated sample size to assert equivalence between groups was not achieved, although the results are suggestive of equivalence.

Bottom line: A shorter course of antimicrobial therapy for complicated intraabdominal infections might lead to equivalent outcomes with less antibiotic exposure compared with current practice; however, it is challenging for providers to stop antimicrobial therapy while patients continue to show physiologic evidence of SIRS.

Citation: Sawyer RG, Claridge JA, Nathens AB, et al. Trial of short-course antimicrobial therapy for intraabdominal infection. NEJM. 2015;372(21):1996-2005.

Clinical question: Does a short, fixed duration of antibiotic therapy for complicated intraabdominal infections lead to equivalent outcomes and less antibiotic exposure than the traditional approach?

Background: Published guidelines recommend appropriate antimicrobial agents for intraabdominal infections, but the optimal duration of therapy remains unclear. Most practitioners continue to treat for 10-14 days and until all physiologic evidence of the systemic inflammatory response syndrome (SIRS) has resolved. More recently, small studies have suggested that a shorter course may lead to equivalent outcomes with decreased antibiotic exposure.

Study design: Open-label, multicenter, randomized control trial.

Setting: Twenty-three sites throughout the U.S. and Canada.

Synopsis: In the short-course group, 257 patients were randomized to receive antimicrobial therapy for four full days after their index source-control procedure; 260 patients in the control group received antimicrobial therapy until two days after resolution of the physiological abnormalities related to SIRS. The median duration of therapy was 4.0 days (interquartile range [IQR], 4.0-5.0) for the experimental group and 8.0 days (IQR 5.0-10.0) in the control group (95% CI, -4.7 to -3.3; P<0.001).

There was no significant difference in surgical site infection, recurrent intraabdominal infection, or death between the experimental and control groups (21.8% vs. 22.3%, 95% CI -7.0 to 8.0; P=0.92). In the experimental group, 47 patients did not adhere to the protocol, all of whom received a longer antimicrobial treatment course than specified in the protocol.

This trial excluded patients without adequate source control and included a small number of immunocompromised hosts. The rate of nonadherence to the protocol was high, at 18% of patients in the experimental group. The calculated sample size to assert equivalence between groups was not achieved, although the results are suggestive of equivalence.

Bottom line: A shorter course of antimicrobial therapy for complicated intraabdominal infections might lead to equivalent outcomes with less antibiotic exposure compared with current practice; however, it is challenging for providers to stop antimicrobial therapy while patients continue to show physiologic evidence of SIRS.

Citation: Sawyer RG, Claridge JA, Nathens AB, et al. Trial of short-course antimicrobial therapy for intraabdominal infection. NEJM. 2015;372(21):1996-2005.

At A Glance

Series: Hospital Medicine: Current Concepts

Title: Clinical Care Conundrums: Challenging Diagnoses in Hospital Medicine

Edited by: James C. Pile, Thomas E. Baudendistel, Brian Harte

Series Editors: Scott Flanders, Sanjay Saint

Pages: 208

---

Clinical Care Conundrums is written in 22 chapters, each discussing a clinical case presentation in a format similar to the series by the same name, published frequently in the Journal of Hospital Medicine.

An expert clinician’s approach to the “clinical conundrums” is disclosed using the presentation of an actual patient case in a prototypical “morning report” style. As in a patient care situation, sequential pieces of information are provided to the expert clinician, who is unfamiliar with the case. The focus of each case is the thought processes of both the clinical team caring for the patient and the commentator.

Each case provides great learning potential, not only in the unusual presentation of common diseases or more typical presentations of unusual diseases, but also in discussions of the possibilities in differential diagnoses. The range of information is wide. Readers are taken through discussions of conditions infrequently encountered but potentially fatal in the event of missed or delayed diagnosis, such as strongyloides hyperinfection, a condition that we are reminded is not always accompanied by eosinophilia. Some discussions of the more common conditions include:

• Evaluation of confusion;
• Etiologies of cirrhosis;
• Malignancies associated with hypercalcemia; and
• Work-up for new-onset seizures.

My interest remained high throughout the book, because I never knew what to expect. For example, a patient presenting with acute chest pain caused by esophageal perforation resulting in delayed diagnosis might follow the index case presentation of Whipple’s disease. We are also reminded that, despite the insistence of Gregory House, MD, (Dr. House is the titular character from the television series “House”) that “it’s never lupus,” it sometimes is actually lupus. A couple of interesting lupus cases are presented in a realistically perplexing manner, followed by beneficial discussion.

Analysis

The real value in this book lies in continued reminders of how and why clinicians make diagnostic errors. In fact, an early chapter in the book deals explicitly with improving diagnostic safety.

Robert Wachter, MD, MHM, reminds us in the introductory chapter that diagnostic errors comprise nearly one in five preventable adverse events. Until recently, diagnostic errors have been given relatively little attention, most likely because they are difficult to measure and harder to fix.

As hospital-based providers, the more awareness we have about the “anatomy and physiology” of both good and faulty decision making, the more likely we are to make better decisions. This book can be a crucial resource for any hospital-based care provider.

---

Dr. Lindsey is medical director of hospital-based physician services at Hospital Corporation of America (HCA).

At A Glance

Series: Hospital Medicine: Current Concepts

Title: Clinical Care Conundrums: Challenging Diagnoses in Hospital Medicine

Edited by: James C. Pile, Thomas E. Baudendistel, Brian Harte

Series Editors: Scott Flanders, Sanjay Saint

Pages: 208

---

Clinical Care Conundrums is written in 22 chapters, each discussing a clinical case presentation in a format similar to the series by the same name, published frequently in the Journal of Hospital Medicine.

An expert clinician’s approach to the “clinical conundrums” is disclosed using the presentation of an actual patient case in a prototypical “morning report” style. As in a patient care situation, sequential pieces of information are provided to the expert clinician, who is unfamiliar with the case. The focus of each case is the thought processes of both the clinical team caring for the patient and the commentator.

Each case provides great learning potential, not only in the unusual presentation of common diseases or more typical presentations of unusual diseases, but also in discussions of the possibilities in differential diagnoses. The range of information is wide. Readers are taken through discussions of conditions infrequently encountered but potentially fatal in the event of missed or delayed diagnosis, such as strongyloides hyperinfection, a condition that we are reminded is not always accompanied by eosinophilia. Some discussions of the more common conditions include:

• Evaluation of confusion;
• Etiologies of cirrhosis;
• Malignancies associated with hypercalcemia; and
• Work-up for new-onset seizures.

My interest remained high throughout the book, because I never knew what to expect. For example, a patient presenting with acute chest pain caused by esophageal perforation resulting in delayed diagnosis might follow the index case presentation of Whipple’s disease. We are also reminded that, despite the insistence of Gregory House, MD, (Dr. House is the titular character from the television series “House”) that “it’s never lupus,” it sometimes is actually lupus. A couple of interesting lupus cases are presented in a realistically perplexing manner, followed by beneficial discussion.

Analysis

The real value in this book lies in continued reminders of how and why clinicians make diagnostic errors. In fact, an early chapter in the book deals explicitly with improving diagnostic safety.

Robert Wachter, MD, MHM, reminds us in the introductory chapter that diagnostic errors comprise nearly one in five preventable adverse events. Until recently, diagnostic errors have been given relatively little attention, most likely because they are difficult to measure and harder to fix.

As hospital-based providers, the more awareness we have about the “anatomy and physiology” of both good and faulty decision making, the more likely we are to make better decisions. This book can be a crucial resource for any hospital-based care provider.

---

Dr. Lindsey is medical director of hospital-based physician services at Hospital Corporation of America (HCA).

At A Glance

Series: Hospital Medicine: Current Concepts

Title: Clinical Care Conundrums: Challenging Diagnoses in Hospital Medicine

Edited by: James C. Pile, Thomas E. Baudendistel, Brian Harte

Series Editors: Scott Flanders, Sanjay Saint

Pages: 208

---

Clinical Care Conundrums is written in 22 chapters, each discussing a clinical case presentation in a format similar to the series by the same name, published frequently in the Journal of Hospital Medicine.

An expert clinician’s approach to the “clinical conundrums” is disclosed using the presentation of an actual patient case in a prototypical “morning report” style. As in a patient care situation, sequential pieces of information are provided to the expert clinician, who is unfamiliar with the case. The focus of each case is the thought processes of both the clinical team caring for the patient and the commentator.

Each case provides great learning potential, not only in the unusual presentation of common diseases or more typical presentations of unusual diseases, but also in discussions of the possibilities in differential diagnoses. The range of information is wide. Readers are taken through discussions of conditions infrequently encountered but potentially fatal in the event of missed or delayed diagnosis, such as strongyloides hyperinfection, a condition that we are reminded is not always accompanied by eosinophilia. Some discussions of the more common conditions include:

• Evaluation of confusion;
• Etiologies of cirrhosis;
• Malignancies associated with hypercalcemia; and
• Work-up for new-onset seizures.

My interest remained high throughout the book, because I never knew what to expect. For example, a patient presenting with acute chest pain caused by esophageal perforation resulting in delayed diagnosis might follow the index case presentation of Whipple’s disease. We are also reminded that, despite the insistence of Gregory House, MD, (Dr. House is the titular character from the television series “House”) that “it’s never lupus,” it sometimes is actually lupus. A couple of interesting lupus cases are presented in a realistically perplexing manner, followed by beneficial discussion.

Analysis

The real value in this book lies in continued reminders of how and why clinicians make diagnostic errors. In fact, an early chapter in the book deals explicitly with improving diagnostic safety.

Robert Wachter, MD, MHM, reminds us in the introductory chapter that diagnostic errors comprise nearly one in five preventable adverse events. Until recently, diagnostic errors have been given relatively little attention, most likely because they are difficult to measure and harder to fix.

As hospital-based providers, the more awareness we have about the “anatomy and physiology” of both good and faulty decision making, the more likely we are to make better decisions. This book can be a crucial resource for any hospital-based care provider.

---

Dr. Lindsey is medical director of hospital-based physician services at Hospital Corporation of America (HCA).

Physicians are lifelong learners by definition. But Elizabeth Cook, MD, is still an actual student.

Dr. Cook, medical director of the hospitalist division of Medical Associates of Central Virginia in Lynchburg, Va., is working toward her master’s degree in public health (MPH) leadership at the University of North Carolina in Chapel Hill, N.C. She is on target to graduate in 2016.

“I am interested in health policy and how the big decisions made at high levels are translated into day-to-day operations,” she says. “Oftentimes the unintended consequences are substantial for some of these decisions. I think it is important for those who do the daily provider work to be a part of the process to help inform the decisions.”

That day-to-day work for Dr. Cook now includes serving as one of seven new members of Team Hospitalist, the volunteer editorial advisory board of The Hospitalist.

Question: Why did you choose a career in medicine?

Answer: A long series of events. My undergrad degree was in television/film/radio production. I was working in the field but was exposed to the field of medicine for the first time after I tore an ACL [anterior cruciate ligament] and had knee surgery. Some friends worked in medicine and, between their encouragement and my fascination with medicine and the way the body works, I decided to change directions and pursued a medical degree.

Q: How/when did you decide to become a hospitalist?

A: I hated inpatient medicine when I was in medical school and as a family practice resident. I intended to open a private practice (family practice) office, but a mentor convinced me to take a job as hospitalist as an interim step while working on putting together the office. I did open the office with intention to transition to just that long term. After doing both for a while, I started to really enjoy the collegiality and pace of hospitalist work and decided to close the office and do hospitalist work full time. That was 14 years ago, and I’ve never second-guessed my decision.

Q: Was there a specific person who steered you to hospital medicine?

A: A part-time faculty member at the residency where I trained really encouraged me to try hospitalist work. He felt like I would enjoy the pace and the ability to interact with specialists and colleagues, and he was absolutely right. I still thank him and sometimes rib him about it when things are really crazy.

Q: What do you like most about working as a hospitalist?

A: I love the pace and the constant interaction with specialists, nursing staff, and other providers. I also have a great group of fellow hospitalists. We have been a very stable group, and some of us have been together for a long time doing this. Almost feels like family. I also like the constant learning that takes place in the interactions with specialists. They keep us on the cutting edge of medicine, and the patients always provide a new and interesting challenge to learn from.

Q: What do you dislike most?

A: We have a very flexible schedule, but it does require lots of weekends and evenings. It makes it hard to have a social life and do things with people outside of medicine who maintain the usual (Monday to Friday) life.

 

Q: What’s the best advice you ever received?

A: Have fun with whatever you are doing.

Q: What’s the biggest change you’ve seen in HM in your career?

A: The patients are much sicker and more complicated than when I first started. We have become really good at managing a lot of things as outpatients, so what is left is a lot of really challenging, time-consuming patients. It’s intellectually rewarding but can be exhausting when you are seeing 16 to 20 patients a day like that.

Q: What’s the biggest change you would like to see in HM?

A: I think we need better coordination with care and more connection to the outpatient setting. I often feel like I am sending my patients out into a black hole, and I just hope they end up with all the things I have ordered and recommended.

Q: For group leaders, why is it important for you to continue seeing patients?

A: Seeing patients is critical. It keeps me in touch with the issues and challenges that my providers deal with. It also creates a sense of teamwork and puts us on equal footing rather than my being perceived as a distant administrator.

Q: As a hospitalist, seeing most of your patients for the very first time, what aspect of patient care is most challenging?

A: Being in the hospital, by its very nature, places patients and families in circumstances that are often scary and out of their control. It creates a lot of emotions that can charge interactions. After so many years, the management and diagnosis can lose their sense of impact for providers, as it is daily routine. It is important to remember the patients’ perspective and learn ways to reassure and inform to defuse some of the high emotions.

Q: What aspect of patient care is most rewarding?

A: When a patient comes in very sick and I am able to identify and treat the problem and watch them make a good recovery. It feels like I am doing something meaningful and important in life.

Q: What is your biggest professional challenge?

A: Interacting with hospital administration, as there are often competing demands and desires that require politics, collaboration, and people skills to get everyone pulling in the same direction.

Q: What’s next professionally?

A: I am not sure. I am eager to see what doors the MPH opens for me. I would be interested in consulting work, helping smaller programs look at opportunities for growth and ways to collaborate and align interests with their hospital administrators. Also, working in health policy interests me.

Q: If you weren’t a doctor, what would you be doing right now?

A: I have written a book and a screenplay and really enjoy that. In my dream world, I would be able to work full time as an author.

---

Richard Quinn is a freelance journalist in New Jersey.

Physicians are lifelong learners by definition. But Elizabeth Cook, MD, is still an actual student.

Dr. Cook, medical director of the hospitalist division of Medical Associates of Central Virginia in Lynchburg, Va., is working toward her master’s degree in public health (MPH) leadership at the University of North Carolina in Chapel Hill, N.C. She is on target to graduate in 2016.

“I am interested in health policy and how the big decisions made at high levels are translated into day-to-day operations,” she says. “Oftentimes the unintended consequences are substantial for some of these decisions. I think it is important for those who do the daily provider work to be a part of the process to help inform the decisions.”

That day-to-day work for Dr. Cook now includes serving as one of seven new members of Team Hospitalist, the volunteer editorial advisory board of The Hospitalist.

Question: Why did you choose a career in medicine?

Answer: A long series of events. My undergrad degree was in television/film/radio production. I was working in the field but was exposed to the field of medicine for the first time after I tore an ACL [anterior cruciate ligament] and had knee surgery. Some friends worked in medicine and, between their encouragement and my fascination with medicine and the way the body works, I decided to change directions and pursued a medical degree.

Q: How/when did you decide to become a hospitalist?

A: I hated inpatient medicine when I was in medical school and as a family practice resident. I intended to open a private practice (family practice) office, but a mentor convinced me to take a job as hospitalist as an interim step while working on putting together the office. I did open the office with intention to transition to just that long term. After doing both for a while, I started to really enjoy the collegiality and pace of hospitalist work and decided to close the office and do hospitalist work full time. That was 14 years ago, and I’ve never second-guessed my decision.

Q: Was there a specific person who steered you to hospital medicine?

A: A part-time faculty member at the residency where I trained really encouraged me to try hospitalist work. He felt like I would enjoy the pace and the ability to interact with specialists and colleagues, and he was absolutely right. I still thank him and sometimes rib him about it when things are really crazy.

Q: What do you like most about working as a hospitalist?

A: I love the pace and the constant interaction with specialists, nursing staff, and other providers. I also have a great group of fellow hospitalists. We have been a very stable group, and some of us have been together for a long time doing this. Almost feels like family. I also like the constant learning that takes place in the interactions with specialists. They keep us on the cutting edge of medicine, and the patients always provide a new and interesting challenge to learn from.

Q: What do you dislike most?

A: We have a very flexible schedule, but it does require lots of weekends and evenings. It makes it hard to have a social life and do things with people outside of medicine who maintain the usual (Monday to Friday) life.

 

Q: What’s the best advice you ever received?

A: Have fun with whatever you are doing.

Q: What’s the biggest change you’ve seen in HM in your career?

A: The patients are much sicker and more complicated than when I first started. We have become really good at managing a lot of things as outpatients, so what is left is a lot of really challenging, time-consuming patients. It’s intellectually rewarding but can be exhausting when you are seeing 16 to 20 patients a day like that.

Q: What’s the biggest change you would like to see in HM?

A: I think we need better coordination with care and more connection to the outpatient setting. I often feel like I am sending my patients out into a black hole, and I just hope they end up with all the things I have ordered and recommended.

Q: For group leaders, why is it important for you to continue seeing patients?

A: Seeing patients is critical. It keeps me in touch with the issues and challenges that my providers deal with. It also creates a sense of teamwork and puts us on equal footing rather than my being perceived as a distant administrator.

Q: As a hospitalist, seeing most of your patients for the very first time, what aspect of patient care is most challenging?

A: Being in the hospital, by its very nature, places patients and families in circumstances that are often scary and out of their control. It creates a lot of emotions that can charge interactions. After so many years, the management and diagnosis can lose their sense of impact for providers, as it is daily routine. It is important to remember the patients’ perspective and learn ways to reassure and inform to defuse some of the high emotions.

Q: What aspect of patient care is most rewarding?

A: When a patient comes in very sick and I am able to identify and treat the problem and watch them make a good recovery. It feels like I am doing something meaningful and important in life.

Q: What is your biggest professional challenge?

A: Interacting with hospital administration, as there are often competing demands and desires that require politics, collaboration, and people skills to get everyone pulling in the same direction.

Q: What’s next professionally?

A: I am not sure. I am eager to see what doors the MPH opens for me. I would be interested in consulting work, helping smaller programs look at opportunities for growth and ways to collaborate and align interests with their hospital administrators. Also, working in health policy interests me.

Q: If you weren’t a doctor, what would you be doing right now?

A: I have written a book and a screenplay and really enjoy that. In my dream world, I would be able to work full time as an author.

---

Richard Quinn is a freelance journalist in New Jersey.

Physicians are lifelong learners by definition. But Elizabeth Cook, MD, is still an actual student.

Dr. Cook, medical director of the hospitalist division of Medical Associates of Central Virginia in Lynchburg, Va., is working toward her master’s degree in public health (MPH) leadership at the University of North Carolina in Chapel Hill, N.C. She is on target to graduate in 2016.

“I am interested in health policy and how the big decisions made at high levels are translated into day-to-day operations,” she says. “Oftentimes the unintended consequences are substantial for some of these decisions. I think it is important for those who do the daily provider work to be a part of the process to help inform the decisions.”

That day-to-day work for Dr. Cook now includes serving as one of seven new members of Team Hospitalist, the volunteer editorial advisory board of The Hospitalist.

Question: Why did you choose a career in medicine?

Answer: A long series of events. My undergrad degree was in television/film/radio production. I was working in the field but was exposed to the field of medicine for the first time after I tore an ACL [anterior cruciate ligament] and had knee surgery. Some friends worked in medicine and, between their encouragement and my fascination with medicine and the way the body works, I decided to change directions and pursued a medical degree.

Q: How/when did you decide to become a hospitalist?

A: I hated inpatient medicine when I was in medical school and as a family practice resident. I intended to open a private practice (family practice) office, but a mentor convinced me to take a job as hospitalist as an interim step while working on putting together the office. I did open the office with intention to transition to just that long term. After doing both for a while, I started to really enjoy the collegiality and pace of hospitalist work and decided to close the office and do hospitalist work full time. That was 14 years ago, and I’ve never second-guessed my decision.

Q: Was there a specific person who steered you to hospital medicine?

A: A part-time faculty member at the residency where I trained really encouraged me to try hospitalist work. He felt like I would enjoy the pace and the ability to interact with specialists and colleagues, and he was absolutely right. I still thank him and sometimes rib him about it when things are really crazy.

Q: What do you like most about working as a hospitalist?

A: I love the pace and the constant interaction with specialists, nursing staff, and other providers. I also have a great group of fellow hospitalists. We have been a very stable group, and some of us have been together for a long time doing this. Almost feels like family. I also like the constant learning that takes place in the interactions with specialists. They keep us on the cutting edge of medicine, and the patients always provide a new and interesting challenge to learn from.

Q: What do you dislike most?

A: We have a very flexible schedule, but it does require lots of weekends and evenings. It makes it hard to have a social life and do things with people outside of medicine who maintain the usual (Monday to Friday) life.

 

Q: What’s the best advice you ever received?

A: Have fun with whatever you are doing.

Q: What’s the biggest change you’ve seen in HM in your career?

A: The patients are much sicker and more complicated than when I first started. We have become really good at managing a lot of things as outpatients, so what is left is a lot of really challenging, time-consuming patients. It’s intellectually rewarding but can be exhausting when you are seeing 16 to 20 patients a day like that.

Q: What’s the biggest change you would like to see in HM?

A: I think we need better coordination with care and more connection to the outpatient setting. I often feel like I am sending my patients out into a black hole, and I just hope they end up with all the things I have ordered and recommended.

Q: For group leaders, why is it important for you to continue seeing patients?

A: Seeing patients is critical. It keeps me in touch with the issues and challenges that my providers deal with. It also creates a sense of teamwork and puts us on equal footing rather than my being perceived as a distant administrator.

Q: As a hospitalist, seeing most of your patients for the very first time, what aspect of patient care is most challenging?

A: Being in the hospital, by its very nature, places patients and families in circumstances that are often scary and out of their control. It creates a lot of emotions that can charge interactions. After so many years, the management and diagnosis can lose their sense of impact for providers, as it is daily routine. It is important to remember the patients’ perspective and learn ways to reassure and inform to defuse some of the high emotions.

Q: What aspect of patient care is most rewarding?

A: When a patient comes in very sick and I am able to identify and treat the problem and watch them make a good recovery. It feels like I am doing something meaningful and important in life.

Q: What is your biggest professional challenge?

A: Interacting with hospital administration, as there are often competing demands and desires that require politics, collaboration, and people skills to get everyone pulling in the same direction.

Q: What’s next professionally?

A: I am not sure. I am eager to see what doors the MPH opens for me. I would be interested in consulting work, helping smaller programs look at opportunities for growth and ways to collaborate and align interests with their hospital administrators. Also, working in health policy interests me.

Q: If you weren’t a doctor, what would you be doing right now?

A: I have written a book and a screenplay and really enjoy that. In my dream world, I would be able to work full time as an author.

---

Richard Quinn is a freelance journalist in New Jersey.

Community hospitals offer multiple opportunities for hospitalists to become involved in both quality assurance and quality improvement. To help steer the right approach and avoid possible missteps, it’s important to acknowledge the differences between the community and academic settings, according to two medical directors with whom we spoke.

For example, in the rural, 47-bed Riverside Tappahannock Hospital where Randy Ferrance, DC, MD, SFHM, is medical director for hospital-based quality, cost effectiveness is king.

“We live on a thin margin, and being sure we provide cost-effective care is the difference between having adequate nursing and not,” he says. It’s a critical difference from academic institutions, he notes, where “there is protected time to do QI, research, and administrative tasks.”

Dr. Ferrance advises those interested in tackling quality projects to “make sure that the project is tied to quality measures and that you’re being cognizant of the cost impact.”

Although much of the work around quality assurance and quality improvement in the community hospital setting is being tackled by nonphysician administrative partners, “those people are usually more than happy to develop a physician partner,” says Colleen A. McCoy, MD, PhD, medical director for hospital medicine at Williamsport (Pa.) Regional Medical Center, a part of the Susquehanna Health System.

“The idea is to look for quality projects where there is a quantifiable financial payoff to the hospital,” she says. That could be a Centers for Medicare and Medicaid Services (CMS) core measure or helping to rewrite an order set for new inpatient guidelines on stroke, as Dr. McCoy did at her hospital.

First Order of Business

Dr. McCoy has been actively engaged in quality initiatives since she joined Williams-port in 2012. She cautions new hospitalists to spend the first six months at their new job developing a reputation for clinical excellence and attention to detail.

“Having a reputation that is respected clinically opens many doors,” she says. As generalists, hospitalists interact with a wider variety of staff than specialists. This leads to broad early exposure to a diverse group of decision makers in your institution. “As a hospitalist, you can get a lot of credibility in your organization much sooner than, for example, a young cardiologist or a young gastroenterologist,” she notes.

It is also important for new hospitalists to be mindful of their position in the organization and to watch how their institutions work and operate, so that when they propose a project they are not doing so from a critical standpoint.

“Unrequested input is often seen as criticism,” she says.

Dr. Ferrance agrees. “It’s always a good idea to make sure we focus on processes and not on people in the process.”

Meeting the Mark

“If you want to leapfrog into doing things quickly, you have to be very savvy about the cost impact of your quality improvement,” continues Dr. McCoy. She and Dr. Ferrance advise those just getting started to consider tackling core measures that are reported to CMS or to identify other quality improvement projects that can be financially quantified.

Early on at Riverside Tappahannock Hospital, Dr. Ferrance participated in root cause analyses and developed (at that time) paper-based standard order sets with quality measures attached to them.

Because of her attention to detail during her orientation at Williamsport, Dr. McCoy, who had been a clinical instructor at Emory University and worked for Kaiser Permanente, quickly spotted some necessary omissions regarding DVT prophylaxis. She helped rewrite the ICU admission order sets, inserting a query for DVT prophylaxis. That one intervention helped to increase compliance on a CMS core measure.

 

Assess Advancement Ops

Is your community hospital open to QI projects? Dr. McCoy says candidates should ask direct questions during job interviews to assess a prospective employer’s approach to quality. She suggests two fair questions:

1. Is it possible, within my first two years here as a junior staff member, to participate in a QI project?
2. If I were successful in that venture, is this organization open and able to give me more opportunities in that field?

It is key for the medical director to know who in the administrative organization of the hospital would really appreciate a physician partner or physician champion for new projects. If young hospitalists are interested in such projects, they should make that known to their medical directors.

“Having the senior person in your group make a connection with your [administrative] partner is how things get done in the community medical center,” Dr. McCoy says.

Dr. Ferrance’s HM group comprises four physicians and one nurse practitioner, so “there are plenty of QI projects to go around.”

“I would be more than happy to give them [junior staff hospitalists] any QI project they are interested in taking on,” he adds. “With medicine evolving as it does, we need to revisit processes every two to three years.” For example, drug shortages and cost increases often necessitate formulary cutbacks and the need for a change in administration protocols.

When selecting a QI project, it pays to stay ahead of the game, Dr. McCoy says. She encourages hospitalists to be aware of the next core measures and volunteer to help develop guidelines. She helped create a new protocol for inpatient tissue plasminogen activator (tPa) evaluation for acute stroke, which was a recent recommendation for stroke center certification. This approach was key in helping Williamsport retain its accreditation as a stroke center. The hospital has garnered multiple accolades from the Joint Commission, U.S. News and World Report, and other reporting agencies.

“The community setting is a much smaller world than academia,” she says. But smaller can be good for one’s career advancement. “If you hit a project out of the park and it makes your hospital look better, you can very quickly get a promotion or an increase in other opportunities. These types of projects may lead to the hospital asking, ‘Have you thought about being director of the hospital medicine group or taking a leadership role in hospital operations?’”

---

Gretchen Henkel is a freelance writer in California.

Community hospitals offer multiple opportunities for hospitalists to become involved in both quality assurance and quality improvement. To help steer the right approach and avoid possible missteps, it’s important to acknowledge the differences between the community and academic settings, according to two medical directors with whom we spoke.

For example, in the rural, 47-bed Riverside Tappahannock Hospital where Randy Ferrance, DC, MD, SFHM, is medical director for hospital-based quality, cost effectiveness is king.

“We live on a thin margin, and being sure we provide cost-effective care is the difference between having adequate nursing and not,” he says. It’s a critical difference from academic institutions, he notes, where “there is protected time to do QI, research, and administrative tasks.”

Dr. Ferrance advises those interested in tackling quality projects to “make sure that the project is tied to quality measures and that you’re being cognizant of the cost impact.”

Although much of the work around quality assurance and quality improvement in the community hospital setting is being tackled by nonphysician administrative partners, “those people are usually more than happy to develop a physician partner,” says Colleen A. McCoy, MD, PhD, medical director for hospital medicine at Williamsport (Pa.) Regional Medical Center, a part of the Susquehanna Health System.

“The idea is to look for quality projects where there is a quantifiable financial payoff to the hospital,” she says. That could be a Centers for Medicare and Medicaid Services (CMS) core measure or helping to rewrite an order set for new inpatient guidelines on stroke, as Dr. McCoy did at her hospital.

First Order of Business

Dr. McCoy has been actively engaged in quality initiatives since she joined Williams-port in 2012. She cautions new hospitalists to spend the first six months at their new job developing a reputation for clinical excellence and attention to detail.

“Having a reputation that is respected clinically opens many doors,” she says. As generalists, hospitalists interact with a wider variety of staff than specialists. This leads to broad early exposure to a diverse group of decision makers in your institution. “As a hospitalist, you can get a lot of credibility in your organization much sooner than, for example, a young cardiologist or a young gastroenterologist,” she notes.

It is also important for new hospitalists to be mindful of their position in the organization and to watch how their institutions work and operate, so that when they propose a project they are not doing so from a critical standpoint.

“Unrequested input is often seen as criticism,” she says.

Dr. Ferrance agrees. “It’s always a good idea to make sure we focus on processes and not on people in the process.”

Meeting the Mark

“If you want to leapfrog into doing things quickly, you have to be very savvy about the cost impact of your quality improvement,” continues Dr. McCoy. She and Dr. Ferrance advise those just getting started to consider tackling core measures that are reported to CMS or to identify other quality improvement projects that can be financially quantified.

Early on at Riverside Tappahannock Hospital, Dr. Ferrance participated in root cause analyses and developed (at that time) paper-based standard order sets with quality measures attached to them.

Because of her attention to detail during her orientation at Williamsport, Dr. McCoy, who had been a clinical instructor at Emory University and worked for Kaiser Permanente, quickly spotted some necessary omissions regarding DVT prophylaxis. She helped rewrite the ICU admission order sets, inserting a query for DVT prophylaxis. That one intervention helped to increase compliance on a CMS core measure.

 

Assess Advancement Ops

Is your community hospital open to QI projects? Dr. McCoy says candidates should ask direct questions during job interviews to assess a prospective employer’s approach to quality. She suggests two fair questions:

1. Is it possible, within my first two years here as a junior staff member, to participate in a QI project?
2. If I were successful in that venture, is this organization open and able to give me more opportunities in that field?

It is key for the medical director to know who in the administrative organization of the hospital would really appreciate a physician partner or physician champion for new projects. If young hospitalists are interested in such projects, they should make that known to their medical directors.

“Having the senior person in your group make a connection with your [administrative] partner is how things get done in the community medical center,” Dr. McCoy says.

Dr. Ferrance’s HM group comprises four physicians and one nurse practitioner, so “there are plenty of QI projects to go around.”

“I would be more than happy to give them [junior staff hospitalists] any QI project they are interested in taking on,” he adds. “With medicine evolving as it does, we need to revisit processes every two to three years.” For example, drug shortages and cost increases often necessitate formulary cutbacks and the need for a change in administration protocols.

When selecting a QI project, it pays to stay ahead of the game, Dr. McCoy says. She encourages hospitalists to be aware of the next core measures and volunteer to help develop guidelines. She helped create a new protocol for inpatient tissue plasminogen activator (tPa) evaluation for acute stroke, which was a recent recommendation for stroke center certification. This approach was key in helping Williamsport retain its accreditation as a stroke center. The hospital has garnered multiple accolades from the Joint Commission, U.S. News and World Report, and other reporting agencies.

“The community setting is a much smaller world than academia,” she says. But smaller can be good for one’s career advancement. “If you hit a project out of the park and it makes your hospital look better, you can very quickly get a promotion or an increase in other opportunities. These types of projects may lead to the hospital asking, ‘Have you thought about being director of the hospital medicine group or taking a leadership role in hospital operations?’”

---

Gretchen Henkel is a freelance writer in California.

Community hospitals offer multiple opportunities for hospitalists to become involved in both quality assurance and quality improvement. To help steer the right approach and avoid possible missteps, it’s important to acknowledge the differences between the community and academic settings, according to two medical directors with whom we spoke.

For example, in the rural, 47-bed Riverside Tappahannock Hospital where Randy Ferrance, DC, MD, SFHM, is medical director for hospital-based quality, cost effectiveness is king.

“We live on a thin margin, and being sure we provide cost-effective care is the difference between having adequate nursing and not,” he says. It’s a critical difference from academic institutions, he notes, where “there is protected time to do QI, research, and administrative tasks.”

Dr. Ferrance advises those interested in tackling quality projects to “make sure that the project is tied to quality measures and that you’re being cognizant of the cost impact.”

Although much of the work around quality assurance and quality improvement in the community hospital setting is being tackled by nonphysician administrative partners, “those people are usually more than happy to develop a physician partner,” says Colleen A. McCoy, MD, PhD, medical director for hospital medicine at Williamsport (Pa.) Regional Medical Center, a part of the Susquehanna Health System.

“The idea is to look for quality projects where there is a quantifiable financial payoff to the hospital,” she says. That could be a Centers for Medicare and Medicaid Services (CMS) core measure or helping to rewrite an order set for new inpatient guidelines on stroke, as Dr. McCoy did at her hospital.

First Order of Business

Dr. McCoy has been actively engaged in quality initiatives since she joined Williams-port in 2012. She cautions new hospitalists to spend the first six months at their new job developing a reputation for clinical excellence and attention to detail.

“Having a reputation that is respected clinically opens many doors,” she says. As generalists, hospitalists interact with a wider variety of staff than specialists. This leads to broad early exposure to a diverse group of decision makers in your institution. “As a hospitalist, you can get a lot of credibility in your organization much sooner than, for example, a young cardiologist or a young gastroenterologist,” she notes.

It is also important for new hospitalists to be mindful of their position in the organization and to watch how their institutions work and operate, so that when they propose a project they are not doing so from a critical standpoint.

“Unrequested input is often seen as criticism,” she says.

Dr. Ferrance agrees. “It’s always a good idea to make sure we focus on processes and not on people in the process.”

Meeting the Mark

“If you want to leapfrog into doing things quickly, you have to be very savvy about the cost impact of your quality improvement,” continues Dr. McCoy. She and Dr. Ferrance advise those just getting started to consider tackling core measures that are reported to CMS or to identify other quality improvement projects that can be financially quantified.

Early on at Riverside Tappahannock Hospital, Dr. Ferrance participated in root cause analyses and developed (at that time) paper-based standard order sets with quality measures attached to them.

Because of her attention to detail during her orientation at Williamsport, Dr. McCoy, who had been a clinical instructor at Emory University and worked for Kaiser Permanente, quickly spotted some necessary omissions regarding DVT prophylaxis. She helped rewrite the ICU admission order sets, inserting a query for DVT prophylaxis. That one intervention helped to increase compliance on a CMS core measure.

 

Assess Advancement Ops

Is your community hospital open to QI projects? Dr. McCoy says candidates should ask direct questions during job interviews to assess a prospective employer’s approach to quality. She suggests two fair questions:

1. Is it possible, within my first two years here as a junior staff member, to participate in a QI project?
2. If I were successful in that venture, is this organization open and able to give me more opportunities in that field?

It is key for the medical director to know who in the administrative organization of the hospital would really appreciate a physician partner or physician champion for new projects. If young hospitalists are interested in such projects, they should make that known to their medical directors.

“Having the senior person in your group make a connection with your [administrative] partner is how things get done in the community medical center,” Dr. McCoy says.

Dr. Ferrance’s HM group comprises four physicians and one nurse practitioner, so “there are plenty of QI projects to go around.”

“I would be more than happy to give them [junior staff hospitalists] any QI project they are interested in taking on,” he adds. “With medicine evolving as it does, we need to revisit processes every two to three years.” For example, drug shortages and cost increases often necessitate formulary cutbacks and the need for a change in administration protocols.

When selecting a QI project, it pays to stay ahead of the game, Dr. McCoy says. She encourages hospitalists to be aware of the next core measures and volunteer to help develop guidelines. She helped create a new protocol for inpatient tissue plasminogen activator (tPa) evaluation for acute stroke, which was a recent recommendation for stroke center certification. This approach was key in helping Williamsport retain its accreditation as a stroke center. The hospital has garnered multiple accolades from the Joint Commission, U.S. News and World Report, and other reporting agencies.

“The community setting is a much smaller world than academia,” she says. But smaller can be good for one’s career advancement. “If you hit a project out of the park and it makes your hospital look better, you can very quickly get a promotion or an increase in other opportunities. These types of projects may lead to the hospital asking, ‘Have you thought about being director of the hospital medicine group or taking a leadership role in hospital operations?’”

---

Gretchen Henkel is a freelance writer in California.

In the wake of proposed changes to the Centers for Medicare and Medicaid Services’ two-midnight rule, physicians say new flexibilities and changes to the policy’s auditing mechanism add more uncertainty and ambiguity.

The 2016 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System proposed rule was published on July 1, 2015, and included changes in response to concerns about portions of the original two-midnight rule.¹ By classifying an inpatient stay as any hospitalization lasting more than two midnights, the rule, which attempted to clarify which services warranted billing under Part B and which qualified for Part A, initially was intended to limit the long observation stays negatively impacting Medicare beneficiaries. However, aggressive reviews by recovery auditors (RAs) and the notion that physician judgment was taking a backseat to arbitrary CMS policy caused a backlash.

In 2014, CMS solicited feedback on the two-midnight rule. SHM suggested a two-tiered approach to address immediate and long-term patient care needs.

“SHM suggests CMS pursue broader solutions to observation status instead of making minor adjustments to the two-midnight rule,” wrote then-SHM President Burke Kealey, MD, SFHM, in a public comment letter to CMS in June 2014. “However, SHM does recognize that in the interim, the two-midnight policy needs to be refined in order to reflect the realities of patient care. Some situations may not be appropriate for classification as outpatient, regardless of the length of stay.”

The proposed changes were supposed to be a solution, but some are saying that CMS has missed the mark. In trying to give physicians more flexibility to determine patient status at the time of admissions, the rule instead may leave physician judgment open to additional scrutiny. Also, the nature of short inpatient stay reviews by Quality Improvement Organizations (QIOs), rather than RAs, remains unclear, and an additional point of concern involves the question of how RAs will factor in.

“My personal opinion is that it will only muddy the waters, in terms of payment for [and] documentation and reviews of short stays for Medicare beneficiaries,” says Jeannine Engel, MD, FACP, in a statement she wrote and shared by email. Dr. Engel is an internist and physician advisor for billing compliance at University of Utah Health Care in Salt Lake City. “No matter who reviews medical documentation, when subjective criteria are used, there is room for interpretation.”

CMS has not defined what constitutes adequate documentation to justify short inpatient stays, nor has it indicated the threshold for “high rates of denials” that would kick reviews over to RAs.

“Details are lacking, and then what makes it even more confusing is what they’ve done with the tweak in policy is further muddied the definition of inpatient,” says Charles Locke, MD, internist and senior physician advisor at Johns Hopkins University School of Medicine in Baltimore. “Whether you agree or disagree with the two-midnight rule, it actually made more clear what inpatient should be.”

According to CMS, the two-midnight rule has reduced observation stays lasting longer than two midnights by 11%, and inpatient admissions are anticipated to increase. But, physicians say, it’s a billing distinction rather than one that impacts patient care.

“The reality is when you take someone in the hospital as outpatient, they can receive every service and care identical to inpatient,” Dr. Locke says. “CMS seems hung up on the idea that in the hospital there are two levels of care.”

 

In fact, with the changes, “CMS had all but abandoned the term ‘inpatient hospital care’ in favor of simply ‘hospital care.’ Now it is back,” says Dr. Engel, who is also a professor of medicine at Huntsman Cancer Institute. “The two-midnight rule was a payment policy, not a ‘care policy.’ Now we may be back to debating what constitutes ‘inpatient care’ versus what could have been ‘safely delivered in a different/lower status such as observation.’”

Dr. Engel and Dr. Locke recently published a study of RAs and the two-midnight rule in the Journal of Hospital Medicine, with University of Wisconsin-Madison School of Medicine and Public Health hospitalist Ann Sheehy, MD.²

The AHA-CMS Quarrel

In addition to SHM, other organizations are heartened by CMS’s responsiveness. Priya Bathija, senior associate director of policy at the American Hospital Association, called them a “step in the right direction,” but also highlighted some of the group’s lingering concerns.

“We think it’s a good thing they’re using QIOs as first-line medical review as opposed to RAs, but we still want to make sure RAs will not make inappropriate denials of claims,” Bathija says.

The AHA is fighting a legal battle against the U.S. Department of Health and Human Services over a 0.2% reduction in inpatient payments through the two-midnight rule, maintained in the proposed changes, which CMS says are warranted based on a projected increase in inpatient service claims.³ The AHA disputes these actuarial values, Bathija says.

The AHA is calling upon CMS to make changes to short stay payments and submitted a letter to CMS outlining six models.⁴ The agency accepted comment on the proposed changes through August 30.

The fundamental issue, however, is that the Medicare payment system is vastly out of date, Dr. Locke says. “What I have advocated is to get rid of Part A and Part B distinction, just like private insurance,” he says, “so when you’re hospitalized, you’re hospitalized, and there is no distinction except inpatient extended, recovery outpatient, or extended outpatient observation.”

If the proposed rule changes are finalized, hospitals are going to have to learn to live with them, despite ambiguous guidance, and adjust their workflow, Dr. Locke says.

“It costs a lot of money and time, and hospitals don’t want to do something thinking they’re doing it in good faith but then the Inspector General says you owe $10 million,” he says. “In general, I and others don’t see this fixing any fundamental problems.”

---

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

References

1. U.S. Department of Health and Human Services. Medicare program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center payment systems and quality reporting programs; short inpatient hospital stays; transition for certain Medicare-dependent, small rural hospitals under the Hospital Inpatient Prospective Payment System. July 1, 2015.  Accessed July 29, 2015.
2. Sheehy AM, Locke C, Engel JZ, et al. Recovery audit contractor audits and appeals at three academic medical centers. J Hosp Med. 2015;10(4):212-219. doi: 10.1002/jhm.2332.
3. American Hospital Association. Associations, hospitals challenge two-midnight rule in federal court. April 14, 2014. Accessed July 29, 2015.
4. Fishman LE. RE: Two-midnight policy and potential short stay payment solutions [letter]. American Hospital Association. February 13, 2015. Accessed July 29, 2015.

In the wake of proposed changes to the Centers for Medicare and Medicaid Services’ two-midnight rule, physicians say new flexibilities and changes to the policy’s auditing mechanism add more uncertainty and ambiguity.

The 2016 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System proposed rule was published on July 1, 2015, and included changes in response to concerns about portions of the original two-midnight rule.¹ By classifying an inpatient stay as any hospitalization lasting more than two midnights, the rule, which attempted to clarify which services warranted billing under Part B and which qualified for Part A, initially was intended to limit the long observation stays negatively impacting Medicare beneficiaries. However, aggressive reviews by recovery auditors (RAs) and the notion that physician judgment was taking a backseat to arbitrary CMS policy caused a backlash.

In 2014, CMS solicited feedback on the two-midnight rule. SHM suggested a two-tiered approach to address immediate and long-term patient care needs.

“SHM suggests CMS pursue broader solutions to observation status instead of making minor adjustments to the two-midnight rule,” wrote then-SHM President Burke Kealey, MD, SFHM, in a public comment letter to CMS in June 2014. “However, SHM does recognize that in the interim, the two-midnight policy needs to be refined in order to reflect the realities of patient care. Some situations may not be appropriate for classification as outpatient, regardless of the length of stay.”

The proposed changes were supposed to be a solution, but some are saying that CMS has missed the mark. In trying to give physicians more flexibility to determine patient status at the time of admissions, the rule instead may leave physician judgment open to additional scrutiny. Also, the nature of short inpatient stay reviews by Quality Improvement Organizations (QIOs), rather than RAs, remains unclear, and an additional point of concern involves the question of how RAs will factor in.

“My personal opinion is that it will only muddy the waters, in terms of payment for [and] documentation and reviews of short stays for Medicare beneficiaries,” says Jeannine Engel, MD, FACP, in a statement she wrote and shared by email. Dr. Engel is an internist and physician advisor for billing compliance at University of Utah Health Care in Salt Lake City. “No matter who reviews medical documentation, when subjective criteria are used, there is room for interpretation.”

CMS has not defined what constitutes adequate documentation to justify short inpatient stays, nor has it indicated the threshold for “high rates of denials” that would kick reviews over to RAs.

“Details are lacking, and then what makes it even more confusing is what they’ve done with the tweak in policy is further muddied the definition of inpatient,” says Charles Locke, MD, internist and senior physician advisor at Johns Hopkins University School of Medicine in Baltimore. “Whether you agree or disagree with the two-midnight rule, it actually made more clear what inpatient should be.”

According to CMS, the two-midnight rule has reduced observation stays lasting longer than two midnights by 11%, and inpatient admissions are anticipated to increase. But, physicians say, it’s a billing distinction rather than one that impacts patient care.

“The reality is when you take someone in the hospital as outpatient, they can receive every service and care identical to inpatient,” Dr. Locke says. “CMS seems hung up on the idea that in the hospital there are two levels of care.”

 

In fact, with the changes, “CMS had all but abandoned the term ‘inpatient hospital care’ in favor of simply ‘hospital care.’ Now it is back,” says Dr. Engel, who is also a professor of medicine at Huntsman Cancer Institute. “The two-midnight rule was a payment policy, not a ‘care policy.’ Now we may be back to debating what constitutes ‘inpatient care’ versus what could have been ‘safely delivered in a different/lower status such as observation.’”

Dr. Engel and Dr. Locke recently published a study of RAs and the two-midnight rule in the Journal of Hospital Medicine, with University of Wisconsin-Madison School of Medicine and Public Health hospitalist Ann Sheehy, MD.²

The AHA-CMS Quarrel

In addition to SHM, other organizations are heartened by CMS’s responsiveness. Priya Bathija, senior associate director of policy at the American Hospital Association, called them a “step in the right direction,” but also highlighted some of the group’s lingering concerns.

“We think it’s a good thing they’re using QIOs as first-line medical review as opposed to RAs, but we still want to make sure RAs will not make inappropriate denials of claims,” Bathija says.

The AHA is fighting a legal battle against the U.S. Department of Health and Human Services over a 0.2% reduction in inpatient payments through the two-midnight rule, maintained in the proposed changes, which CMS says are warranted based on a projected increase in inpatient service claims.³ The AHA disputes these actuarial values, Bathija says.

The AHA is calling upon CMS to make changes to short stay payments and submitted a letter to CMS outlining six models.⁴ The agency accepted comment on the proposed changes through August 30.

The fundamental issue, however, is that the Medicare payment system is vastly out of date, Dr. Locke says. “What I have advocated is to get rid of Part A and Part B distinction, just like private insurance,” he says, “so when you’re hospitalized, you’re hospitalized, and there is no distinction except inpatient extended, recovery outpatient, or extended outpatient observation.”

If the proposed rule changes are finalized, hospitals are going to have to learn to live with them, despite ambiguous guidance, and adjust their workflow, Dr. Locke says.

“It costs a lot of money and time, and hospitals don’t want to do something thinking they’re doing it in good faith but then the Inspector General says you owe $10 million,” he says. “In general, I and others don’t see this fixing any fundamental problems.”

---

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

References

1. U.S. Department of Health and Human Services. Medicare program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center payment systems and quality reporting programs; short inpatient hospital stays; transition for certain Medicare-dependent, small rural hospitals under the Hospital Inpatient Prospective Payment System. July 1, 2015.  Accessed July 29, 2015.
2. Sheehy AM, Locke C, Engel JZ, et al. Recovery audit contractor audits and appeals at three academic medical centers. J Hosp Med. 2015;10(4):212-219. doi: 10.1002/jhm.2332.
3. American Hospital Association. Associations, hospitals challenge two-midnight rule in federal court. April 14, 2014. Accessed July 29, 2015.
4. Fishman LE. RE: Two-midnight policy and potential short stay payment solutions [letter]. American Hospital Association. February 13, 2015. Accessed July 29, 2015.

In the wake of proposed changes to the Centers for Medicare and Medicaid Services’ two-midnight rule, physicians say new flexibilities and changes to the policy’s auditing mechanism add more uncertainty and ambiguity.

The 2016 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System proposed rule was published on July 1, 2015, and included changes in response to concerns about portions of the original two-midnight rule.¹ By classifying an inpatient stay as any hospitalization lasting more than two midnights, the rule, which attempted to clarify which services warranted billing under Part B and which qualified for Part A, initially was intended to limit the long observation stays negatively impacting Medicare beneficiaries. However, aggressive reviews by recovery auditors (RAs) and the notion that physician judgment was taking a backseat to arbitrary CMS policy caused a backlash.

In 2014, CMS solicited feedback on the two-midnight rule. SHM suggested a two-tiered approach to address immediate and long-term patient care needs.

“SHM suggests CMS pursue broader solutions to observation status instead of making minor adjustments to the two-midnight rule,” wrote then-SHM President Burke Kealey, MD, SFHM, in a public comment letter to CMS in June 2014. “However, SHM does recognize that in the interim, the two-midnight policy needs to be refined in order to reflect the realities of patient care. Some situations may not be appropriate for classification as outpatient, regardless of the length of stay.”

The proposed changes were supposed to be a solution, but some are saying that CMS has missed the mark. In trying to give physicians more flexibility to determine patient status at the time of admissions, the rule instead may leave physician judgment open to additional scrutiny. Also, the nature of short inpatient stay reviews by Quality Improvement Organizations (QIOs), rather than RAs, remains unclear, and an additional point of concern involves the question of how RAs will factor in.

“My personal opinion is that it will only muddy the waters, in terms of payment for [and] documentation and reviews of short stays for Medicare beneficiaries,” says Jeannine Engel, MD, FACP, in a statement she wrote and shared by email. Dr. Engel is an internist and physician advisor for billing compliance at University of Utah Health Care in Salt Lake City. “No matter who reviews medical documentation, when subjective criteria are used, there is room for interpretation.”

CMS has not defined what constitutes adequate documentation to justify short inpatient stays, nor has it indicated the threshold for “high rates of denials” that would kick reviews over to RAs.

“Details are lacking, and then what makes it even more confusing is what they’ve done with the tweak in policy is further muddied the definition of inpatient,” says Charles Locke, MD, internist and senior physician advisor at Johns Hopkins University School of Medicine in Baltimore. “Whether you agree or disagree with the two-midnight rule, it actually made more clear what inpatient should be.”

According to CMS, the two-midnight rule has reduced observation stays lasting longer than two midnights by 11%, and inpatient admissions are anticipated to increase. But, physicians say, it’s a billing distinction rather than one that impacts patient care.

“The reality is when you take someone in the hospital as outpatient, they can receive every service and care identical to inpatient,” Dr. Locke says. “CMS seems hung up on the idea that in the hospital there are two levels of care.”

 

In fact, with the changes, “CMS had all but abandoned the term ‘inpatient hospital care’ in favor of simply ‘hospital care.’ Now it is back,” says Dr. Engel, who is also a professor of medicine at Huntsman Cancer Institute. “The two-midnight rule was a payment policy, not a ‘care policy.’ Now we may be back to debating what constitutes ‘inpatient care’ versus what could have been ‘safely delivered in a different/lower status such as observation.’”

Dr. Engel and Dr. Locke recently published a study of RAs and the two-midnight rule in the Journal of Hospital Medicine, with University of Wisconsin-Madison School of Medicine and Public Health hospitalist Ann Sheehy, MD.²

The AHA-CMS Quarrel

In addition to SHM, other organizations are heartened by CMS’s responsiveness. Priya Bathija, senior associate director of policy at the American Hospital Association, called them a “step in the right direction,” but also highlighted some of the group’s lingering concerns.

“We think it’s a good thing they’re using QIOs as first-line medical review as opposed to RAs, but we still want to make sure RAs will not make inappropriate denials of claims,” Bathija says.

The AHA is fighting a legal battle against the U.S. Department of Health and Human Services over a 0.2% reduction in inpatient payments through the two-midnight rule, maintained in the proposed changes, which CMS says are warranted based on a projected increase in inpatient service claims.³ The AHA disputes these actuarial values, Bathija says.

The AHA is calling upon CMS to make changes to short stay payments and submitted a letter to CMS outlining six models.⁴ The agency accepted comment on the proposed changes through August 30.

The fundamental issue, however, is that the Medicare payment system is vastly out of date, Dr. Locke says. “What I have advocated is to get rid of Part A and Part B distinction, just like private insurance,” he says, “so when you’re hospitalized, you’re hospitalized, and there is no distinction except inpatient extended, recovery outpatient, or extended outpatient observation.”

If the proposed rule changes are finalized, hospitals are going to have to learn to live with them, despite ambiguous guidance, and adjust their workflow, Dr. Locke says.

“It costs a lot of money and time, and hospitals don’t want to do something thinking they’re doing it in good faith but then the Inspector General says you owe $10 million,” he says. “In general, I and others don’t see this fixing any fundamental problems.”

---

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

References

1. U.S. Department of Health and Human Services. Medicare program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center payment systems and quality reporting programs; short inpatient hospital stays; transition for certain Medicare-dependent, small rural hospitals under the Hospital Inpatient Prospective Payment System. July 1, 2015.  Accessed July 29, 2015.
2. Sheehy AM, Locke C, Engel JZ, et al. Recovery audit contractor audits and appeals at three academic medical centers. J Hosp Med. 2015;10(4):212-219. doi: 10.1002/jhm.2332.
3. American Hospital Association. Associations, hospitals challenge two-midnight rule in federal court. April 14, 2014. Accessed July 29, 2015.
4. Fishman LE. RE: Two-midnight policy and potential short stay payment solutions [letter]. American Hospital Association. February 13, 2015. Accessed July 29, 2015.

Clinical question: In patients undergoing noncardiac surgery, are peri-operative beta blockers beneficial in those at high risk and harmful in those at low risk?

Background: Despite multiple RCTs, the exact utility of peri-operative beta-blockade remains unclear, especially in those patients considered low cardiac risk. While initial research prompted guidelines that encouraged the liberal use of peri-operative beta blockers, more recent studies have drawn attention to their potential adverse effects, prompting further investigation.

Study design: Retrospective, observational, cohort study.

Setting: One hundred nineteen Veterans Administration medical centers.

Synopsis: Through the modeling of data from 326,489 patients who underwent noncardiac surgery between 2008 and 2013, this study assessed the effects of beta blocker usage and cardiac risk factors on 30-day surgical mortality.

Analysis demonstrated a significant difference in the effect of beta blocker use on mortality based on the number of cardiac risk factors. For patients with no cardiac risk factors, those receiving beta blockers were at increased risk of death (odds ratio 1.19, 95% confidence interval 1.06-1.35). Among patients with three to four cardiac risk factors, however, those on beta blockers had a decreased risk of death (odds ratio 0.63, 95% confidence interval 0.43-0.93).

Bottom line: In noncardiac surgery, use of beta blockers may be beneficial for those at high cardiac risk and detrimental to those without cardiac risk factors.

Citation: Friedell ML, Van Way CW 3rd, Freyberg RW, Almenoff PL. Beta-blockade and operative mortality in noncardiac surgery: harmful or helpful? JAMA Surgery. 2015;150(7):658-664. doi:10.1001/jamasurg.2015.86.

Clinical question: In patients undergoing noncardiac surgery, are peri-operative beta blockers beneficial in those at high risk and harmful in those at low risk?

Background: Despite multiple RCTs, the exact utility of peri-operative beta-blockade remains unclear, especially in those patients considered low cardiac risk. While initial research prompted guidelines that encouraged the liberal use of peri-operative beta blockers, more recent studies have drawn attention to their potential adverse effects, prompting further investigation.

Study design: Retrospective, observational, cohort study.

Setting: One hundred nineteen Veterans Administration medical centers.

Synopsis: Through the modeling of data from 326,489 patients who underwent noncardiac surgery between 2008 and 2013, this study assessed the effects of beta blocker usage and cardiac risk factors on 30-day surgical mortality.

Analysis demonstrated a significant difference in the effect of beta blocker use on mortality based on the number of cardiac risk factors. For patients with no cardiac risk factors, those receiving beta blockers were at increased risk of death (odds ratio 1.19, 95% confidence interval 1.06-1.35). Among patients with three to four cardiac risk factors, however, those on beta blockers had a decreased risk of death (odds ratio 0.63, 95% confidence interval 0.43-0.93).

Bottom line: In noncardiac surgery, use of beta blockers may be beneficial for those at high cardiac risk and detrimental to those without cardiac risk factors.

Citation: Friedell ML, Van Way CW 3rd, Freyberg RW, Almenoff PL. Beta-blockade and operative mortality in noncardiac surgery: harmful or helpful? JAMA Surgery. 2015;150(7):658-664. doi:10.1001/jamasurg.2015.86.

Clinical question: In patients undergoing noncardiac surgery, are peri-operative beta blockers beneficial in those at high risk and harmful in those at low risk?

Background: Despite multiple RCTs, the exact utility of peri-operative beta-blockade remains unclear, especially in those patients considered low cardiac risk. While initial research prompted guidelines that encouraged the liberal use of peri-operative beta blockers, more recent studies have drawn attention to their potential adverse effects, prompting further investigation.

Study design: Retrospective, observational, cohort study.

Setting: One hundred nineteen Veterans Administration medical centers.

Synopsis: Through the modeling of data from 326,489 patients who underwent noncardiac surgery between 2008 and 2013, this study assessed the effects of beta blocker usage and cardiac risk factors on 30-day surgical mortality.

Analysis demonstrated a significant difference in the effect of beta blocker use on mortality based on the number of cardiac risk factors. For patients with no cardiac risk factors, those receiving beta blockers were at increased risk of death (odds ratio 1.19, 95% confidence interval 1.06-1.35). Among patients with three to four cardiac risk factors, however, those on beta blockers had a decreased risk of death (odds ratio 0.63, 95% confidence interval 0.43-0.93).

Bottom line: In noncardiac surgery, use of beta blockers may be beneficial for those at high cardiac risk and detrimental to those without cardiac risk factors.

Citation: Friedell ML, Van Way CW 3rd, Freyberg RW, Almenoff PL. Beta-blockade and operative mortality in noncardiac surgery: harmful or helpful? JAMA Surgery. 2015;150(7):658-664. doi:10.1001/jamasurg.2015.86.

Clinical question: Do stable, low-risk patients hospitalized for chest pain after negative ED evaluation experience adverse cardiac events in the hospital?

Background: Chest pain results in more than seven million ED visits annually, with a cost of over $11 billion to hospitalize these patients for closer monitoring. It is not well known to what extent these low-risk patients experience in-hospital adverse cardiac events after a negative ED evaluation.

Study design: Blinded data review from a prospectively collected, multicenter database.

Setting: Three community teaching hospitals in the U.S.

Synopsis: Researchers identified 11,230 patients, aged 18 and older, hospitalized with chest pain symptoms after negative serial troponin, from July 2008 through June 2013. Demographics included mean age 58 years, 55% female, with several co-morbid medical illnesses. One hundred ninety-seven patients met the primary outcomes of in-hospital life-threatening arrhythmia, ST segment elevation MI, cardiac or respiratory arrest, and death.

Blinded reviewers further stratified these patients and excluded any patients with initial abnormal vital signs, with ECG evidence of ischemia, or with an uninterpretable ECG. This resulted in four patients who experienced the primary outcome in hospital after presenting with chest pain, stable vital signs, and no evidence of ischemia. By verifying inclusion data from 5% of the primary cohort and extrapolating, they calculated a primary outcome incidence of 0.06% [95% CI, 0.02%-0.14%].

Results were in hospital only and were not time specific. Authors were unable to control for confounders, prevent data collection bias, or verify inclusion criteria for more than 5% of the initial sample.

Bottom line: Risk for in-hospital adverse cardiac events is low in patients hospitalized from the ED with chest pain and normal vital signs, negative serial troponin, and non-ischemic ECG.

Citation: Weinstock MB, Weingart S, Orth F, et al. Risk for clinically relevant adverse cardiac events in patients with chest pain at hospital admission. JAMA Intern Med. 2015;175(7):1207-1212. doi: 10.1001/jamainternmed.2015.1674.

Clinical question: Do stable, low-risk patients hospitalized for chest pain after negative ED evaluation experience adverse cardiac events in the hospital?

Background: Chest pain results in more than seven million ED visits annually, with a cost of over $11 billion to hospitalize these patients for closer monitoring. It is not well known to what extent these low-risk patients experience in-hospital adverse cardiac events after a negative ED evaluation.

Study design: Blinded data review from a prospectively collected, multicenter database.

Setting: Three community teaching hospitals in the U.S.

Synopsis: Researchers identified 11,230 patients, aged 18 and older, hospitalized with chest pain symptoms after negative serial troponin, from July 2008 through June 2013. Demographics included mean age 58 years, 55% female, with several co-morbid medical illnesses. One hundred ninety-seven patients met the primary outcomes of in-hospital life-threatening arrhythmia, ST segment elevation MI, cardiac or respiratory arrest, and death.

Blinded reviewers further stratified these patients and excluded any patients with initial abnormal vital signs, with ECG evidence of ischemia, or with an uninterpretable ECG. This resulted in four patients who experienced the primary outcome in hospital after presenting with chest pain, stable vital signs, and no evidence of ischemia. By verifying inclusion data from 5% of the primary cohort and extrapolating, they calculated a primary outcome incidence of 0.06% [95% CI, 0.02%-0.14%].

Results were in hospital only and were not time specific. Authors were unable to control for confounders, prevent data collection bias, or verify inclusion criteria for more than 5% of the initial sample.

Bottom line: Risk for in-hospital adverse cardiac events is low in patients hospitalized from the ED with chest pain and normal vital signs, negative serial troponin, and non-ischemic ECG.

Citation: Weinstock MB, Weingart S, Orth F, et al. Risk for clinically relevant adverse cardiac events in patients with chest pain at hospital admission. JAMA Intern Med. 2015;175(7):1207-1212. doi: 10.1001/jamainternmed.2015.1674.

Clinical question: Do stable, low-risk patients hospitalized for chest pain after negative ED evaluation experience adverse cardiac events in the hospital?

Background: Chest pain results in more than seven million ED visits annually, with a cost of over $11 billion to hospitalize these patients for closer monitoring. It is not well known to what extent these low-risk patients experience in-hospital adverse cardiac events after a negative ED evaluation.

Study design: Blinded data review from a prospectively collected, multicenter database.

Setting: Three community teaching hospitals in the U.S.

Synopsis: Researchers identified 11,230 patients, aged 18 and older, hospitalized with chest pain symptoms after negative serial troponin, from July 2008 through June 2013. Demographics included mean age 58 years, 55% female, with several co-morbid medical illnesses. One hundred ninety-seven patients met the primary outcomes of in-hospital life-threatening arrhythmia, ST segment elevation MI, cardiac or respiratory arrest, and death.

Blinded reviewers further stratified these patients and excluded any patients with initial abnormal vital signs, with ECG evidence of ischemia, or with an uninterpretable ECG. This resulted in four patients who experienced the primary outcome in hospital after presenting with chest pain, stable vital signs, and no evidence of ischemia. By verifying inclusion data from 5% of the primary cohort and extrapolating, they calculated a primary outcome incidence of 0.06% [95% CI, 0.02%-0.14%].

Results were in hospital only and were not time specific. Authors were unable to control for confounders, prevent data collection bias, or verify inclusion criteria for more than 5% of the initial sample.

Bottom line: Risk for in-hospital adverse cardiac events is low in patients hospitalized from the ED with chest pain and normal vital signs, negative serial troponin, and non-ischemic ECG.

Citation: Weinstock MB, Weingart S, Orth F, et al. Risk for clinically relevant adverse cardiac events in patients with chest pain at hospital admission. JAMA Intern Med. 2015;175(7):1207-1212. doi: 10.1001/jamainternmed.2015.1674.

Solomon Noguera, MD, is the new assistant medical director at Serenity HospiceCare in Farmington, Mo. Dr. Noguera most recently served as a hospitalist for both St. Anthony’s Hospital in St. Louis and St. Genevieve (Mo.) Hospital. He also practices primary care at Millennium Medical PC in Festus, Mo., and attends to patients at several other St. Louis-area hospitals.

Jeremy Souder, MD, FHM, recently was awarded the Young Alumni Achievement Award from Juniata College in Huntingdon, Pa. Dr. Souder is a hospitalist, clinical assistant professor of medicine, and medical director of the Inpatient Palliative Care Program at Pennsylvania Hospital in Philadelphia.

Ahmad T. Haq, MD, MBA, has been appointed director of the hospital medicine service at South Georgia Medical Center (SGMC) in Valdosta, Ga. Dr. Haq comes to SGMC from his role as director of hospital medicine at Grand Strand Regional Medical Center in Myrtle Beach, S.C. Dallas-based EmCare oversees SGMC’s hospitalist program.

Leonard Castiglione is the new chief executive officer of Ob Hospitalist Group (OBHG). Castiglione joins the Greenville, S.C.-based company after recently serving as CEO of Florida Gulf to Bay Anesthesia Holdings, LLC, in Tampa, Fla. OBHG has been providing OB/GYN emergency and hospitalist services since 2006.

Mengistu Yemane, MD, is the new hospitalist medical director at Henry County Medical Center (HCMC) in Paris, Tenn. Dr. Yemane most recently served as chief medical officer and director of the hospitalist program at Manchester Memorial Hospital in Manchester, Ky. HCMC is a 142-bed, nonprofit, acute care facility serving Henry County in Tennessee.

Beth Hawley, MBA, SFHM, has been named senior vice president of strategic initiatives for IPC Healthcare, Inc., based in North Hollywood, Calif. Hawley comes to IPC from her role as chief customer experience officer at Cogent Healthcare (now part of Sound Physicians).

We’re always looking for hospitalists “on the move”? Send us details of your recent award, promotion, or business deal to Jason Carris.

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Business Moves

Fresenius Medical Care North America (FMCNA), based in Waltham, Mass., recently appeared on Forbes magazine’s “America’s Best Employers List for 2015.” FMCNA, a hospitalist services and renal care provider, was listed as third in the category of Health Care Equipment and Services. FMCNA operates renal care centers and hospitalist physician practices in all 50 states.

IPC Healthcare, Inc., based in North Hollywood, Calif., recently announced its acquisition of two post-acute care groups. Extended Care Physicians (ECP), based in Asheville, N.C., is one of the largest private post-acute care firms in the region. Geriatric Associates of America (GAA), based in Houston, provides post-acute geriatric care throughout the Houston, San Antonio, and Dallas areas. IPC Healthcare employs over 1,900 clinicians in more than 400 hospitals and 1,700 post-acute care facilities nationwide.

WellStar Kennestone Hospital in Marietta, Ga., announced its new pediatric inpatient unit at a ribbon-cutting ceremony in June. The new unit will staff four hospitalists, 12 nurses, five clinical care partners, four respiratory therapists, two managers, and one pharmacist. WellStar Kennestone Hospital is a 586-bed acute care facility serving the greater Marietta area.

Solomon Noguera, MD, is the new assistant medical director at Serenity HospiceCare in Farmington, Mo. Dr. Noguera most recently served as a hospitalist for both St. Anthony’s Hospital in St. Louis and St. Genevieve (Mo.) Hospital. He also practices primary care at Millennium Medical PC in Festus, Mo., and attends to patients at several other St. Louis-area hospitals.

Jeremy Souder, MD, FHM, recently was awarded the Young Alumni Achievement Award from Juniata College in Huntingdon, Pa. Dr. Souder is a hospitalist, clinical assistant professor of medicine, and medical director of the Inpatient Palliative Care Program at Pennsylvania Hospital in Philadelphia.

Ahmad T. Haq, MD, MBA, has been appointed director of the hospital medicine service at South Georgia Medical Center (SGMC) in Valdosta, Ga. Dr. Haq comes to SGMC from his role as director of hospital medicine at Grand Strand Regional Medical Center in Myrtle Beach, S.C. Dallas-based EmCare oversees SGMC’s hospitalist program.

Leonard Castiglione is the new chief executive officer of Ob Hospitalist Group (OBHG). Castiglione joins the Greenville, S.C.-based company after recently serving as CEO of Florida Gulf to Bay Anesthesia Holdings, LLC, in Tampa, Fla. OBHG has been providing OB/GYN emergency and hospitalist services since 2006.

Mengistu Yemane, MD, is the new hospitalist medical director at Henry County Medical Center (HCMC) in Paris, Tenn. Dr. Yemane most recently served as chief medical officer and director of the hospitalist program at Manchester Memorial Hospital in Manchester, Ky. HCMC is a 142-bed, nonprofit, acute care facility serving Henry County in Tennessee.

Beth Hawley, MBA, SFHM, has been named senior vice president of strategic initiatives for IPC Healthcare, Inc., based in North Hollywood, Calif. Hawley comes to IPC from her role as chief customer experience officer at Cogent Healthcare (now part of Sound Physicians).

We’re always looking for hospitalists “on the move”? Send us details of your recent award, promotion, or business deal to Jason Carris.

---

Business Moves

Fresenius Medical Care North America (FMCNA), based in Waltham, Mass., recently appeared on Forbes magazine’s “America’s Best Employers List for 2015.” FMCNA, a hospitalist services and renal care provider, was listed as third in the category of Health Care Equipment and Services. FMCNA operates renal care centers and hospitalist physician practices in all 50 states.

IPC Healthcare, Inc., based in North Hollywood, Calif., recently announced its acquisition of two post-acute care groups. Extended Care Physicians (ECP), based in Asheville, N.C., is one of the largest private post-acute care firms in the region. Geriatric Associates of America (GAA), based in Houston, provides post-acute geriatric care throughout the Houston, San Antonio, and Dallas areas. IPC Healthcare employs over 1,900 clinicians in more than 400 hospitals and 1,700 post-acute care facilities nationwide.

WellStar Kennestone Hospital in Marietta, Ga., announced its new pediatric inpatient unit at a ribbon-cutting ceremony in June. The new unit will staff four hospitalists, 12 nurses, five clinical care partners, four respiratory therapists, two managers, and one pharmacist. WellStar Kennestone Hospital is a 586-bed acute care facility serving the greater Marietta area.

Solomon Noguera, MD, is the new assistant medical director at Serenity HospiceCare in Farmington, Mo. Dr. Noguera most recently served as a hospitalist for both St. Anthony’s Hospital in St. Louis and St. Genevieve (Mo.) Hospital. He also practices primary care at Millennium Medical PC in Festus, Mo., and attends to patients at several other St. Louis-area hospitals.

Jeremy Souder, MD, FHM, recently was awarded the Young Alumni Achievement Award from Juniata College in Huntingdon, Pa. Dr. Souder is a hospitalist, clinical assistant professor of medicine, and medical director of the Inpatient Palliative Care Program at Pennsylvania Hospital in Philadelphia.

Ahmad T. Haq, MD, MBA, has been appointed director of the hospital medicine service at South Georgia Medical Center (SGMC) in Valdosta, Ga. Dr. Haq comes to SGMC from his role as director of hospital medicine at Grand Strand Regional Medical Center in Myrtle Beach, S.C. Dallas-based EmCare oversees SGMC’s hospitalist program.

Leonard Castiglione is the new chief executive officer of Ob Hospitalist Group (OBHG). Castiglione joins the Greenville, S.C.-based company after recently serving as CEO of Florida Gulf to Bay Anesthesia Holdings, LLC, in Tampa, Fla. OBHG has been providing OB/GYN emergency and hospitalist services since 2006.

Mengistu Yemane, MD, is the new hospitalist medical director at Henry County Medical Center (HCMC) in Paris, Tenn. Dr. Yemane most recently served as chief medical officer and director of the hospitalist program at Manchester Memorial Hospital in Manchester, Ky. HCMC is a 142-bed, nonprofit, acute care facility serving Henry County in Tennessee.

Beth Hawley, MBA, SFHM, has been named senior vice president of strategic initiatives for IPC Healthcare, Inc., based in North Hollywood, Calif. Hawley comes to IPC from her role as chief customer experience officer at Cogent Healthcare (now part of Sound Physicians).

We’re always looking for hospitalists “on the move”? Send us details of your recent award, promotion, or business deal to Jason Carris.

---

Business Moves

Fresenius Medical Care North America (FMCNA), based in Waltham, Mass., recently appeared on Forbes magazine’s “America’s Best Employers List for 2015.” FMCNA, a hospitalist services and renal care provider, was listed as third in the category of Health Care Equipment and Services. FMCNA operates renal care centers and hospitalist physician practices in all 50 states.

IPC Healthcare, Inc., based in North Hollywood, Calif., recently announced its acquisition of two post-acute care groups. Extended Care Physicians (ECP), based in Asheville, N.C., is one of the largest private post-acute care firms in the region. Geriatric Associates of America (GAA), based in Houston, provides post-acute geriatric care throughout the Houston, San Antonio, and Dallas areas. IPC Healthcare employs over 1,900 clinicians in more than 400 hospitals and 1,700 post-acute care facilities nationwide.

WellStar Kennestone Hospital in Marietta, Ga., announced its new pediatric inpatient unit at a ribbon-cutting ceremony in June. The new unit will staff four hospitalists, 12 nurses, five clinical care partners, four respiratory therapists, two managers, and one pharmacist. WellStar Kennestone Hospital is a 586-bed acute care facility serving the greater Marietta area.

Novel anticoagulants will likely replace need for vitamin K antagonists

BY MADHUKAR S. PATEL, M.D., AND ELLIOT L. CHAIKOF, M.D.

The discovery of oral anticoagulants began in 1924, when Schofield linked the death of grazing cattle from internal hemorrhage to the consumption of spoiled sweet clover hay.¹ It was not until 1941, however, while trying to understand this observation, that Campbell & Link were able to identify the dicoumarol anticoagulant, which formed as a result of the spoiling process.² Ultimately, after noting that vitamin K led to reversal of the dicoumarol effect, synthesis of the first class of oral anticoagulants, known as vitamin K antagonists (VKAs), began.

Despite the numerous challenges associated with managing patients using this class of anticoagulants, VKAs have become the mainstay of oral anticoagulation therapy for the past 70 years. Over the past 5 years, however, new oral anticoagulants (NOACs) have emerged and are changing clinical practice.

Mechanistically, these medications are targeted therapies and work as either direct thrombin inhibitors (dabigatran etexilate) or direct factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban). Given their favorable pharmacologic design, NOACs have the potential to replace VKAs as they not only have an encouraging safety profile, but also are therapeutically equivalent or even superior to VKAs when used in certain patient populations.

Pharmacologic design

The targeted drug design of NOACs provides many pharmacologic advantages. Compared to VKAs, NOACs have a notably more predictable pharmacologic profile and relatively wide therapeutic window, which allows for fixed dosing, a rapid onset and offset, and fewer drug interactions.³ These characteristics eliminate the need for the routine dose monitoring and serial dose adjustments frequently associated with VKAs.

NOACs less commonly require bridging therapy with parenteral unfractionated heparin or low-molecular-weight heparins (LMWH) while awaiting therapeutic drug levels, as these levels are reached sooner and more predictably than with VKAs.⁴ As with any medication, however, appropriate consideration should to be given to specific patient populations such as those who are older or have significant comorbidities that may influence drug effect and clearance. Lastly, it should be mentioned that the pharmacologic benefits of NOACs apply not only from a patient perspective, but also from a health care systems standpoint, as their use may provide an opportunity to deliver more cost-effective care.

Specifically, economic models using available clinical trial data for stroke prevention in nonvalvular atrial fibrillation have shown that NOACs (apixaban, dabigatran, and rivaroxaban) are cost-effective alternatives when compared to warfarin.⁵ Although the results from such economic analyses are limited by the modeling assumptions they rely upon, these findings suggest that at least initially, cost should not be used as a prohibitive reason for adopting these new therapeutics.

Patient selection

The decision to institute oral anticoagulation therapy depends on each patient’s individualized bleeding risk to benefit of ischemia prevention ratio. A major determinant of this ratio is the clinical indication for which anticoagulation is begun. Numerous phase III clinical trials have been conducted comparing the use of NOACs to VKAs or placebos for the management of nonvalvular atrial fibrillation and venous thromboembolism, and as adjunctive therapy for patients with acute coronary syndrome.⁶

Meta-analyses of randomized trials have shown the most significant benefit to be in patients with nonvalvular atrial fibrillation, where NOACs yield significant reductions in stroke, intracranial hemorrhage, and all-cause mortality compared to warfarin, while displaying variable effects with regard to gastrointestinal bleeding.^6,7 In patients with VTE, NOACs have been found to have efficacy similar to that of VKAs with regard to the prevention of VTE or VTE-related death, and have been noted to have a better safety profile.⁶

Lastly, when studied as an adjunctive agent to dual antiplatelet therapy in patients with acute coronary syndrome, NOACs have been associated with an increased bleeding risk without a significant decrease in thrombosis risk.⁶ Taken together, these data suggest that the primary indication for instituting NOAC therapy should be considered strongly when deciding upon which class of anticoagulant to use.

Overcoming challenges

Since the introduction of NOACs, there has been concern over the lack of specific antidotes to therapy, especially when administered in patients with impaired clearance, a high likelihood of need for an urgent or emergent procedure, or those presenting with life threatening bleeding complications.

Most recently, however, interim analysis from clinical trial data has shown complete reversal of the direct thrombin inhibitor dabigatran with the humanized monoclonal antibody idarucizumab within minutes of administration in greater than 88% of patients studied.⁸ Similarly, agents such as a PER977 are currently under phase II clinical trials as they have been shown to form noncovalent hydrogen bonds and charge-charge interactions with oral factor Xa inhibitors as well as oral thrombin inhibitors leading to their reversal.⁹

 

Given these promising findings, it likely will not be long until reversal agents for NOACs become clinically available. Until that time, it is encouraging that the bleeding profile of these drugs has been found to be favorable compared to VKAs and their short half-life allows for a relatively expeditious natural reversal of their anticoagulant effect as the drug is eliminated.

Conclusion

Unlike the serendipitous path leading to the discovery of the first class of oral anticoagulants (VKAs), NOACs have been specifically designed to provide targeted anticoagulation and to address the shortcomings of VKAs. To this end, NOACs are becoming increasingly important in the management of patients with specific clinical conditions such as nonvalvular atrial fibrillation and venous thromboembolism, where they have been shown to provide a larger net clinical benefit relative to the available alternatives. Furthermore, with economic analyses providing evidence that NOACs are cost-effective for the healthcare system and clinical trial results suggesting progress in the development of antidotes for reversal, it is likely that with growing experience, these agents will replace VKAs as the mainstay for prophylactic and therapeutic oral anticoagulation in targeted patient populations.

Dr. Patel is a research fellow and Dr. Chaikof is surgeon-in-chief, both at the department of surgery, Beth Israel Deaconess Medical Center, Boston. They reported no conflicts of interest.

References

1. J Am Vet Med Assoc. 1924;64:553-75 (See Br J Haematol 2008 Mar 18;141[6]:757-63).

2. J Biol Chem. 1941;138:21-33 (See Nutr Rev. 1974 Aug;32[8]:244-6).

3. Am Soc Hematol Educ Program. 2013;2013:464-70.

4. Eur Heart J. 2013 Jul;34(27):2094-2106.

5. Stroke. 2013 Jun;44(6):1676-81.

6. Nat Rev Cardiol. 2014 Dec;11(12):693-703.

7. Lancet. 2014 Mar 15;383(9921):955-62.

8. N Engl J Med. 2015;373(6):511-20.

9. N Engl J Med. 2014;371(22):2141-2.

What the doctor didn’t order: unintended consequences and pitfalls of NOACs

BY THOMAS WAKEFIELD, M.D., ANDREA OBI, M.D., AND DAWN COLEMAN, M.D.

Recently, several new oral anticoagulants have gained FDA approval to replace warfarin, capturing the attention of popular media. These include dabigatran, rivaroxaban, apixaban, and edoxaban. Dabigatran targets activated factor II (factor IIa), while rivaroxaban, apixaban, and edoxaban target activated factor X (factor Xa). Easy to take with a once- or twice-daily pill, with no cumbersome monitoring, they represent a seemingly ideal treatment for the chronically anticoagulated patient. All agents are currently FDA approved in the United States for treatment of acute venous thromboembolism (VTE) and atrial fibrillation (AF).

Dabigatran and edoxaban

As with warfarin, dabigatran and edoxaban require the use of a low-molecular-weight heparin (LMWH) or unfractionated heparin “bridge” when therapy is beginning, while rivaroxaban and apixaban are instituted as monotherapy without such a bridge. Dabigatran etexilate (PradaxaR, Boehringer Ingelheim) has the longest half-life of all of the NOACs at 12-17 hours, and this half-life is prolonged with increasing age and decreasing renal function.¹ It is the only new agent that can be at least partially reversed with dialysis.² Edoxaban (SavaysaR, Daiichi Sankyo) carries a boxed warning stating that this agent is less effective in AF patients with a creatinine clearance greater than 95 mL/min, and that kidney function should be assessed prior to starting treatment: Such patients have a greater risk of stroke compared with similar patients treated with warfarin. Edoxaban is the only agent specifically tested at a lower dose in patients at significantly increased risk of bleeding complications (low body weight and/or decreased creatinine clearance).³

Rivaroxaban and apixaban

Rivaroxaban (XareltoR, Bayer and Janssen), and apixaban (EliquisR, Bristol Myers-Squibb), unique among the NOACs, have been tested for extended therapy of acute DVT after treatment of 6-12 months. They were found to result in a significant decrease in recurrent VTE without an increase in major bleeding compared to placebo.^4,5 Rivaroxaban has once-daily dosing and apixaban has twice-daily dosing; both are immediate monotherapy, making them quite convenient for patients. Apixaban is the only agent among the NOACs to have a slight decrease in gastrointestinal bleeding compared to warfarin.⁶

Consequences and pitfalls with NOACs

Problems with these new drugs, which may diminish our current level of enthusiasm for these agents to totally replace warfarin, include the inability to reliably follow their levels and to reverse their anticoagulant effects, the lack of data available on bridging when other procedures need to be performed, their short half-lives, and the lack of data on their anti-inflammatory effects.

With regard to monitoring of anticoagulation, the International Society of Thrombosis and Hemostasis (ISTH) has published a recommendation⁷ that lists these scenarios:

• When a patient is bleeding.

• Before surgery or an invasive procedure when the patient has taken the drug in the previous 24 hours, or longer if creatinine clearance (CrCl) is less than 50 mL/min.

 

• Identification of subtherapeutic or supratherapeutic levels in patients taking other drugs that are known to affect pharmacokinetics.

• Identification of subtherapeutic or supratherapeutic levels in patients at body weight extremes.

• Patients with deteriorating renal function.

• During perioperative management.

• During reversal of anticoagulation.

• When there is suspicion of overdose.

• Assessment of compliance in patients suffering thrombotic events while on treatment.

Currently, there exists no commercially available reversal agent for any of the NOACs and existing reversal agents for traditional anticoagulants are of limited, if any, use. Drugs under development include agents for the factor Xa inhibitors and for the thrombin inhibitor. Until the time that specific reversal agents exist, supportive care is the mainstay of therapy. In cases of trauma or severe or life-threatening bleeding, administration of concentrated clotting factors (prothrombin complex concentrate) or dialysis (dabigatran only) may be utilized. However, data from large clinical trials is lacking. A recent study of 90 patients receiving an antibody directed against dabigatran has revealed that the anticoagulant effects of dabigatran were reversed safely within minutes of administration; however, drug levels were not consistently suppressed at 24 hours in 20% of the cohort.⁸

There are no national guidelines nor large scale studies to guide bridging NOACs for procedures. The relatively short half-life for these agents makes it likely that traditional bridging as is practiced for warfarin is not necessary.⁹ However, this represents a double edged sword; withholding anticoagulation for two doses (such as if a patient becomes ill or a clinician is overly cautious around the time of a procedure) may leave the patient unprotected.

The final question with the new agents is their anti-inflammatory effects. We know that heparin and LMWH have significant pleiotropic effects that are not necessarily related to their anticoagulant effects. These effects are important to decrease the inflammatory nature of the thrombus and its effect on the vein wall. We do not know if the new oral agents have similar effects, as this has never fully been tested. In view of the fact that two of the agents are being used as monotherapy agents without any heparin/LMWH bridge, the anti-inflammatory properties of these new agents should be defined to make sure that such a bridge is not necessary.

Conclusion

So, in summary, although these agents have much to offer, there are many questions that remain to be addressed and answered before they totally replace traditional approaches to anticoagulation, in the realm of VTE. It must not be overlooked that for all the benefits, they each carry a risk of bleeding as they all target portions of the coagulation mechanism. We believe, that as with any “gift horse,” physicians should perhaps examine the data more closely and proceed with caution.

Dr. Wakefield is director of the Samuel and Jean Frankel Cardiovascular Center, Dr. Obi is a vascular surgery fellow, and Dr. Coleman is program director, section of vascular surgery, at the University of Michigan, Ann Arbor. They reported no conflicts of interest.

References

1. N Engl J Med. 2009;361:2342-52.

2. J Vasc Surg: Venous Lymphat Disord. 2013;1:418-26.

3. N Engl J Med. 2013;369:1406-15.

4. N Engl J Med. 2010;363:2499-2510.

5. N Engl J Med. 2013;368:699-708.

6. Arterioscler Thromb Vasc Biol. 2015;35:1056-65.

7. J Thromb Haemost. 2013;11:756-60.

8. N Engl J Med. 2015;373:511-20.

9. Curr Opin Anaesthesiol. 2014;27:409-19.

Novel anticoagulants will likely replace need for vitamin K antagonists

BY MADHUKAR S. PATEL, M.D., AND ELLIOT L. CHAIKOF, M.D.

The discovery of oral anticoagulants began in 1924, when Schofield linked the death of grazing cattle from internal hemorrhage to the consumption of spoiled sweet clover hay.¹ It was not until 1941, however, while trying to understand this observation, that Campbell & Link were able to identify the dicoumarol anticoagulant, which formed as a result of the spoiling process.² Ultimately, after noting that vitamin K led to reversal of the dicoumarol effect, synthesis of the first class of oral anticoagulants, known as vitamin K antagonists (VKAs), began.

Despite the numerous challenges associated with managing patients using this class of anticoagulants, VKAs have become the mainstay of oral anticoagulation therapy for the past 70 years. Over the past 5 years, however, new oral anticoagulants (NOACs) have emerged and are changing clinical practice.

Mechanistically, these medications are targeted therapies and work as either direct thrombin inhibitors (dabigatran etexilate) or direct factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban). Given their favorable pharmacologic design, NOACs have the potential to replace VKAs as they not only have an encouraging safety profile, but also are therapeutically equivalent or even superior to VKAs when used in certain patient populations.

Pharmacologic design

The targeted drug design of NOACs provides many pharmacologic advantages. Compared to VKAs, NOACs have a notably more predictable pharmacologic profile and relatively wide therapeutic window, which allows for fixed dosing, a rapid onset and offset, and fewer drug interactions.³ These characteristics eliminate the need for the routine dose monitoring and serial dose adjustments frequently associated with VKAs.

NOACs less commonly require bridging therapy with parenteral unfractionated heparin or low-molecular-weight heparins (LMWH) while awaiting therapeutic drug levels, as these levels are reached sooner and more predictably than with VKAs.⁴ As with any medication, however, appropriate consideration should to be given to specific patient populations such as those who are older or have significant comorbidities that may influence drug effect and clearance. Lastly, it should be mentioned that the pharmacologic benefits of NOACs apply not only from a patient perspective, but also from a health care systems standpoint, as their use may provide an opportunity to deliver more cost-effective care.

Specifically, economic models using available clinical trial data for stroke prevention in nonvalvular atrial fibrillation have shown that NOACs (apixaban, dabigatran, and rivaroxaban) are cost-effective alternatives when compared to warfarin.⁵ Although the results from such economic analyses are limited by the modeling assumptions they rely upon, these findings suggest that at least initially, cost should not be used as a prohibitive reason for adopting these new therapeutics.

Patient selection

The decision to institute oral anticoagulation therapy depends on each patient’s individualized bleeding risk to benefit of ischemia prevention ratio. A major determinant of this ratio is the clinical indication for which anticoagulation is begun. Numerous phase III clinical trials have been conducted comparing the use of NOACs to VKAs or placebos for the management of nonvalvular atrial fibrillation and venous thromboembolism, and as adjunctive therapy for patients with acute coronary syndrome.⁶

Meta-analyses of randomized trials have shown the most significant benefit to be in patients with nonvalvular atrial fibrillation, where NOACs yield significant reductions in stroke, intracranial hemorrhage, and all-cause mortality compared to warfarin, while displaying variable effects with regard to gastrointestinal bleeding.^6,7 In patients with VTE, NOACs have been found to have efficacy similar to that of VKAs with regard to the prevention of VTE or VTE-related death, and have been noted to have a better safety profile.⁶

Lastly, when studied as an adjunctive agent to dual antiplatelet therapy in patients with acute coronary syndrome, NOACs have been associated with an increased bleeding risk without a significant decrease in thrombosis risk.⁶ Taken together, these data suggest that the primary indication for instituting NOAC therapy should be considered strongly when deciding upon which class of anticoagulant to use.

Overcoming challenges

Since the introduction of NOACs, there has been concern over the lack of specific antidotes to therapy, especially when administered in patients with impaired clearance, a high likelihood of need for an urgent or emergent procedure, or those presenting with life threatening bleeding complications.

Most recently, however, interim analysis from clinical trial data has shown complete reversal of the direct thrombin inhibitor dabigatran with the humanized monoclonal antibody idarucizumab within minutes of administration in greater than 88% of patients studied.⁸ Similarly, agents such as a PER977 are currently under phase II clinical trials as they have been shown to form noncovalent hydrogen bonds and charge-charge interactions with oral factor Xa inhibitors as well as oral thrombin inhibitors leading to their reversal.⁹

 

Given these promising findings, it likely will not be long until reversal agents for NOACs become clinically available. Until that time, it is encouraging that the bleeding profile of these drugs has been found to be favorable compared to VKAs and their short half-life allows for a relatively expeditious natural reversal of their anticoagulant effect as the drug is eliminated.

Conclusion

Unlike the serendipitous path leading to the discovery of the first class of oral anticoagulants (VKAs), NOACs have been specifically designed to provide targeted anticoagulation and to address the shortcomings of VKAs. To this end, NOACs are becoming increasingly important in the management of patients with specific clinical conditions such as nonvalvular atrial fibrillation and venous thromboembolism, where they have been shown to provide a larger net clinical benefit relative to the available alternatives. Furthermore, with economic analyses providing evidence that NOACs are cost-effective for the healthcare system and clinical trial results suggesting progress in the development of antidotes for reversal, it is likely that with growing experience, these agents will replace VKAs as the mainstay for prophylactic and therapeutic oral anticoagulation in targeted patient populations.

Dr. Patel is a research fellow and Dr. Chaikof is surgeon-in-chief, both at the department of surgery, Beth Israel Deaconess Medical Center, Boston. They reported no conflicts of interest.

References

1. J Am Vet Med Assoc. 1924;64:553-75 (See Br J Haematol 2008 Mar 18;141[6]:757-63).

2. J Biol Chem. 1941;138:21-33 (See Nutr Rev. 1974 Aug;32[8]:244-6).

3. Am Soc Hematol Educ Program. 2013;2013:464-70.

4. Eur Heart J. 2013 Jul;34(27):2094-2106.

5. Stroke. 2013 Jun;44(6):1676-81.

6. Nat Rev Cardiol. 2014 Dec;11(12):693-703.

7. Lancet. 2014 Mar 15;383(9921):955-62.

8. N Engl J Med. 2015;373(6):511-20.

9. N Engl J Med. 2014;371(22):2141-2.

What the doctor didn’t order: unintended consequences and pitfalls of NOACs

BY THOMAS WAKEFIELD, M.D., ANDREA OBI, M.D., AND DAWN COLEMAN, M.D.

Recently, several new oral anticoagulants have gained FDA approval to replace warfarin, capturing the attention of popular media. These include dabigatran, rivaroxaban, apixaban, and edoxaban. Dabigatran targets activated factor II (factor IIa), while rivaroxaban, apixaban, and edoxaban target activated factor X (factor Xa). Easy to take with a once- or twice-daily pill, with no cumbersome monitoring, they represent a seemingly ideal treatment for the chronically anticoagulated patient. All agents are currently FDA approved in the United States for treatment of acute venous thromboembolism (VTE) and atrial fibrillation (AF).

Dabigatran and edoxaban

As with warfarin, dabigatran and edoxaban require the use of a low-molecular-weight heparin (LMWH) or unfractionated heparin “bridge” when therapy is beginning, while rivaroxaban and apixaban are instituted as monotherapy without such a bridge. Dabigatran etexilate (PradaxaR, Boehringer Ingelheim) has the longest half-life of all of the NOACs at 12-17 hours, and this half-life is prolonged with increasing age and decreasing renal function.¹ It is the only new agent that can be at least partially reversed with dialysis.² Edoxaban (SavaysaR, Daiichi Sankyo) carries a boxed warning stating that this agent is less effective in AF patients with a creatinine clearance greater than 95 mL/min, and that kidney function should be assessed prior to starting treatment: Such patients have a greater risk of stroke compared with similar patients treated with warfarin. Edoxaban is the only agent specifically tested at a lower dose in patients at significantly increased risk of bleeding complications (low body weight and/or decreased creatinine clearance).³

Rivaroxaban and apixaban

Rivaroxaban (XareltoR, Bayer and Janssen), and apixaban (EliquisR, Bristol Myers-Squibb), unique among the NOACs, have been tested for extended therapy of acute DVT after treatment of 6-12 months. They were found to result in a significant decrease in recurrent VTE without an increase in major bleeding compared to placebo.^4,5 Rivaroxaban has once-daily dosing and apixaban has twice-daily dosing; both are immediate monotherapy, making them quite convenient for patients. Apixaban is the only agent among the NOACs to have a slight decrease in gastrointestinal bleeding compared to warfarin.⁶

Consequences and pitfalls with NOACs

Problems with these new drugs, which may diminish our current level of enthusiasm for these agents to totally replace warfarin, include the inability to reliably follow their levels and to reverse their anticoagulant effects, the lack of data available on bridging when other procedures need to be performed, their short half-lives, and the lack of data on their anti-inflammatory effects.

With regard to monitoring of anticoagulation, the International Society of Thrombosis and Hemostasis (ISTH) has published a recommendation⁷ that lists these scenarios:

• When a patient is bleeding.

• Before surgery or an invasive procedure when the patient has taken the drug in the previous 24 hours, or longer if creatinine clearance (CrCl) is less than 50 mL/min.

 

• Identification of subtherapeutic or supratherapeutic levels in patients taking other drugs that are known to affect pharmacokinetics.

• Identification of subtherapeutic or supratherapeutic levels in patients at body weight extremes.

• Patients with deteriorating renal function.

• During perioperative management.

• During reversal of anticoagulation.

• When there is suspicion of overdose.

• Assessment of compliance in patients suffering thrombotic events while on treatment.

Currently, there exists no commercially available reversal agent for any of the NOACs and existing reversal agents for traditional anticoagulants are of limited, if any, use. Drugs under development include agents for the factor Xa inhibitors and for the thrombin inhibitor. Until the time that specific reversal agents exist, supportive care is the mainstay of therapy. In cases of trauma or severe or life-threatening bleeding, administration of concentrated clotting factors (prothrombin complex concentrate) or dialysis (dabigatran only) may be utilized. However, data from large clinical trials is lacking. A recent study of 90 patients receiving an antibody directed against dabigatran has revealed that the anticoagulant effects of dabigatran were reversed safely within minutes of administration; however, drug levels were not consistently suppressed at 24 hours in 20% of the cohort.⁸

There are no national guidelines nor large scale studies to guide bridging NOACs for procedures. The relatively short half-life for these agents makes it likely that traditional bridging as is practiced for warfarin is not necessary.⁹ However, this represents a double edged sword; withholding anticoagulation for two doses (such as if a patient becomes ill or a clinician is overly cautious around the time of a procedure) may leave the patient unprotected.

The final question with the new agents is their anti-inflammatory effects. We know that heparin and LMWH have significant pleiotropic effects that are not necessarily related to their anticoagulant effects. These effects are important to decrease the inflammatory nature of the thrombus and its effect on the vein wall. We do not know if the new oral agents have similar effects, as this has never fully been tested. In view of the fact that two of the agents are being used as monotherapy agents without any heparin/LMWH bridge, the anti-inflammatory properties of these new agents should be defined to make sure that such a bridge is not necessary.

Conclusion

So, in summary, although these agents have much to offer, there are many questions that remain to be addressed and answered before they totally replace traditional approaches to anticoagulation, in the realm of VTE. It must not be overlooked that for all the benefits, they each carry a risk of bleeding as they all target portions of the coagulation mechanism. We believe, that as with any “gift horse,” physicians should perhaps examine the data more closely and proceed with caution.

Dr. Wakefield is director of the Samuel and Jean Frankel Cardiovascular Center, Dr. Obi is a vascular surgery fellow, and Dr. Coleman is program director, section of vascular surgery, at the University of Michigan, Ann Arbor. They reported no conflicts of interest.

References

1. N Engl J Med. 2009;361:2342-52.

2. J Vasc Surg: Venous Lymphat Disord. 2013;1:418-26.

3. N Engl J Med. 2013;369:1406-15.

4. N Engl J Med. 2010;363:2499-2510.

5. N Engl J Med. 2013;368:699-708.

6. Arterioscler Thromb Vasc Biol. 2015;35:1056-65.

7. J Thromb Haemost. 2013;11:756-60.

8. N Engl J Med. 2015;373:511-20.

9. Curr Opin Anaesthesiol. 2014;27:409-19.

Novel anticoagulants will likely replace need for vitamin K antagonists

BY MADHUKAR S. PATEL, M.D., AND ELLIOT L. CHAIKOF, M.D.

The discovery of oral anticoagulants began in 1924, when Schofield linked the death of grazing cattle from internal hemorrhage to the consumption of spoiled sweet clover hay.¹ It was not until 1941, however, while trying to understand this observation, that Campbell & Link were able to identify the dicoumarol anticoagulant, which formed as a result of the spoiling process.² Ultimately, after noting that vitamin K led to reversal of the dicoumarol effect, synthesis of the first class of oral anticoagulants, known as vitamin K antagonists (VKAs), began.

Despite the numerous challenges associated with managing patients using this class of anticoagulants, VKAs have become the mainstay of oral anticoagulation therapy for the past 70 years. Over the past 5 years, however, new oral anticoagulants (NOACs) have emerged and are changing clinical practice.

Mechanistically, these medications are targeted therapies and work as either direct thrombin inhibitors (dabigatran etexilate) or direct factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban). Given their favorable pharmacologic design, NOACs have the potential to replace VKAs as they not only have an encouraging safety profile, but also are therapeutically equivalent or even superior to VKAs when used in certain patient populations.

Pharmacologic design

The targeted drug design of NOACs provides many pharmacologic advantages. Compared to VKAs, NOACs have a notably more predictable pharmacologic profile and relatively wide therapeutic window, which allows for fixed dosing, a rapid onset and offset, and fewer drug interactions.³ These characteristics eliminate the need for the routine dose monitoring and serial dose adjustments frequently associated with VKAs.

NOACs less commonly require bridging therapy with parenteral unfractionated heparin or low-molecular-weight heparins (LMWH) while awaiting therapeutic drug levels, as these levels are reached sooner and more predictably than with VKAs.⁴ As with any medication, however, appropriate consideration should to be given to specific patient populations such as those who are older or have significant comorbidities that may influence drug effect and clearance. Lastly, it should be mentioned that the pharmacologic benefits of NOACs apply not only from a patient perspective, but also from a health care systems standpoint, as their use may provide an opportunity to deliver more cost-effective care.

Specifically, economic models using available clinical trial data for stroke prevention in nonvalvular atrial fibrillation have shown that NOACs (apixaban, dabigatran, and rivaroxaban) are cost-effective alternatives when compared to warfarin.⁵ Although the results from such economic analyses are limited by the modeling assumptions they rely upon, these findings suggest that at least initially, cost should not be used as a prohibitive reason for adopting these new therapeutics.

Patient selection

The decision to institute oral anticoagulation therapy depends on each patient’s individualized bleeding risk to benefit of ischemia prevention ratio. A major determinant of this ratio is the clinical indication for which anticoagulation is begun. Numerous phase III clinical trials have been conducted comparing the use of NOACs to VKAs or placebos for the management of nonvalvular atrial fibrillation and venous thromboembolism, and as adjunctive therapy for patients with acute coronary syndrome.⁶

Meta-analyses of randomized trials have shown the most significant benefit to be in patients with nonvalvular atrial fibrillation, where NOACs yield significant reductions in stroke, intracranial hemorrhage, and all-cause mortality compared to warfarin, while displaying variable effects with regard to gastrointestinal bleeding.^6,7 In patients with VTE, NOACs have been found to have efficacy similar to that of VKAs with regard to the prevention of VTE or VTE-related death, and have been noted to have a better safety profile.⁶

Lastly, when studied as an adjunctive agent to dual antiplatelet therapy in patients with acute coronary syndrome, NOACs have been associated with an increased bleeding risk without a significant decrease in thrombosis risk.⁶ Taken together, these data suggest that the primary indication for instituting NOAC therapy should be considered strongly when deciding upon which class of anticoagulant to use.

Overcoming challenges

Since the introduction of NOACs, there has been concern over the lack of specific antidotes to therapy, especially when administered in patients with impaired clearance, a high likelihood of need for an urgent or emergent procedure, or those presenting with life threatening bleeding complications.

Most recently, however, interim analysis from clinical trial data has shown complete reversal of the direct thrombin inhibitor dabigatran with the humanized monoclonal antibody idarucizumab within minutes of administration in greater than 88% of patients studied.⁸ Similarly, agents such as a PER977 are currently under phase II clinical trials as they have been shown to form noncovalent hydrogen bonds and charge-charge interactions with oral factor Xa inhibitors as well as oral thrombin inhibitors leading to their reversal.⁹

 

Given these promising findings, it likely will not be long until reversal agents for NOACs become clinically available. Until that time, it is encouraging that the bleeding profile of these drugs has been found to be favorable compared to VKAs and their short half-life allows for a relatively expeditious natural reversal of their anticoagulant effect as the drug is eliminated.

Conclusion

Unlike the serendipitous path leading to the discovery of the first class of oral anticoagulants (VKAs), NOACs have been specifically designed to provide targeted anticoagulation and to address the shortcomings of VKAs. To this end, NOACs are becoming increasingly important in the management of patients with specific clinical conditions such as nonvalvular atrial fibrillation and venous thromboembolism, where they have been shown to provide a larger net clinical benefit relative to the available alternatives. Furthermore, with economic analyses providing evidence that NOACs are cost-effective for the healthcare system and clinical trial results suggesting progress in the development of antidotes for reversal, it is likely that with growing experience, these agents will replace VKAs as the mainstay for prophylactic and therapeutic oral anticoagulation in targeted patient populations.

Dr. Patel is a research fellow and Dr. Chaikof is surgeon-in-chief, both at the department of surgery, Beth Israel Deaconess Medical Center, Boston. They reported no conflicts of interest.

References

1. J Am Vet Med Assoc. 1924;64:553-75 (See Br J Haematol 2008 Mar 18;141[6]:757-63).

2. J Biol Chem. 1941;138:21-33 (See Nutr Rev. 1974 Aug;32[8]:244-6).

3. Am Soc Hematol Educ Program. 2013;2013:464-70.

4. Eur Heart J. 2013 Jul;34(27):2094-2106.

5. Stroke. 2013 Jun;44(6):1676-81.

6. Nat Rev Cardiol. 2014 Dec;11(12):693-703.

7. Lancet. 2014 Mar 15;383(9921):955-62.

8. N Engl J Med. 2015;373(6):511-20.

9. N Engl J Med. 2014;371(22):2141-2.

What the doctor didn’t order: unintended consequences and pitfalls of NOACs

BY THOMAS WAKEFIELD, M.D., ANDREA OBI, M.D., AND DAWN COLEMAN, M.D.

Recently, several new oral anticoagulants have gained FDA approval to replace warfarin, capturing the attention of popular media. These include dabigatran, rivaroxaban, apixaban, and edoxaban. Dabigatran targets activated factor II (factor IIa), while rivaroxaban, apixaban, and edoxaban target activated factor X (factor Xa). Easy to take with a once- or twice-daily pill, with no cumbersome monitoring, they represent a seemingly ideal treatment for the chronically anticoagulated patient. All agents are currently FDA approved in the United States for treatment of acute venous thromboembolism (VTE) and atrial fibrillation (AF).

Dabigatran and edoxaban

As with warfarin, dabigatran and edoxaban require the use of a low-molecular-weight heparin (LMWH) or unfractionated heparin “bridge” when therapy is beginning, while rivaroxaban and apixaban are instituted as monotherapy without such a bridge. Dabigatran etexilate (PradaxaR, Boehringer Ingelheim) has the longest half-life of all of the NOACs at 12-17 hours, and this half-life is prolonged with increasing age and decreasing renal function.¹ It is the only new agent that can be at least partially reversed with dialysis.² Edoxaban (SavaysaR, Daiichi Sankyo) carries a boxed warning stating that this agent is less effective in AF patients with a creatinine clearance greater than 95 mL/min, and that kidney function should be assessed prior to starting treatment: Such patients have a greater risk of stroke compared with similar patients treated with warfarin. Edoxaban is the only agent specifically tested at a lower dose in patients at significantly increased risk of bleeding complications (low body weight and/or decreased creatinine clearance).³

Rivaroxaban and apixaban

Rivaroxaban (XareltoR, Bayer and Janssen), and apixaban (EliquisR, Bristol Myers-Squibb), unique among the NOACs, have been tested for extended therapy of acute DVT after treatment of 6-12 months. They were found to result in a significant decrease in recurrent VTE without an increase in major bleeding compared to placebo.^4,5 Rivaroxaban has once-daily dosing and apixaban has twice-daily dosing; both are immediate monotherapy, making them quite convenient for patients. Apixaban is the only agent among the NOACs to have a slight decrease in gastrointestinal bleeding compared to warfarin.⁶

Consequences and pitfalls with NOACs

Problems with these new drugs, which may diminish our current level of enthusiasm for these agents to totally replace warfarin, include the inability to reliably follow their levels and to reverse their anticoagulant effects, the lack of data available on bridging when other procedures need to be performed, their short half-lives, and the lack of data on their anti-inflammatory effects.

With regard to monitoring of anticoagulation, the International Society of Thrombosis and Hemostasis (ISTH) has published a recommendation⁷ that lists these scenarios:

• When a patient is bleeding.

• Before surgery or an invasive procedure when the patient has taken the drug in the previous 24 hours, or longer if creatinine clearance (CrCl) is less than 50 mL/min.

 

• Identification of subtherapeutic or supratherapeutic levels in patients taking other drugs that are known to affect pharmacokinetics.

• Identification of subtherapeutic or supratherapeutic levels in patients at body weight extremes.

• Patients with deteriorating renal function.

• During perioperative management.

• During reversal of anticoagulation.

• When there is suspicion of overdose.

• Assessment of compliance in patients suffering thrombotic events while on treatment.

Currently, there exists no commercially available reversal agent for any of the NOACs and existing reversal agents for traditional anticoagulants are of limited, if any, use. Drugs under development include agents for the factor Xa inhibitors and for the thrombin inhibitor. Until the time that specific reversal agents exist, supportive care is the mainstay of therapy. In cases of trauma or severe or life-threatening bleeding, administration of concentrated clotting factors (prothrombin complex concentrate) or dialysis (dabigatran only) may be utilized. However, data from large clinical trials is lacking. A recent study of 90 patients receiving an antibody directed against dabigatran has revealed that the anticoagulant effects of dabigatran were reversed safely within minutes of administration; however, drug levels were not consistently suppressed at 24 hours in 20% of the cohort.⁸

There are no national guidelines nor large scale studies to guide bridging NOACs for procedures. The relatively short half-life for these agents makes it likely that traditional bridging as is practiced for warfarin is not necessary.⁹ However, this represents a double edged sword; withholding anticoagulation for two doses (such as if a patient becomes ill or a clinician is overly cautious around the time of a procedure) may leave the patient unprotected.

The final question with the new agents is their anti-inflammatory effects. We know that heparin and LMWH have significant pleiotropic effects that are not necessarily related to their anticoagulant effects. These effects are important to decrease the inflammatory nature of the thrombus and its effect on the vein wall. We do not know if the new oral agents have similar effects, as this has never fully been tested. In view of the fact that two of the agents are being used as monotherapy agents without any heparin/LMWH bridge, the anti-inflammatory properties of these new agents should be defined to make sure that such a bridge is not necessary.

Conclusion

So, in summary, although these agents have much to offer, there are many questions that remain to be addressed and answered before they totally replace traditional approaches to anticoagulation, in the realm of VTE. It must not be overlooked that for all the benefits, they each carry a risk of bleeding as they all target portions of the coagulation mechanism. We believe, that as with any “gift horse,” physicians should perhaps examine the data more closely and proceed with caution.

Dr. Wakefield is director of the Samuel and Jean Frankel Cardiovascular Center, Dr. Obi is a vascular surgery fellow, and Dr. Coleman is program director, section of vascular surgery, at the University of Michigan, Ann Arbor. They reported no conflicts of interest.

References

1. N Engl J Med. 2009;361:2342-52.

2. J Vasc Surg: Venous Lymphat Disord. 2013;1:418-26.

3. N Engl J Med. 2013;369:1406-15.

4. N Engl J Med. 2010;363:2499-2510.

5. N Engl J Med. 2013;368:699-708.

6. Arterioscler Thromb Vasc Biol. 2015;35:1056-65.

7. J Thromb Haemost. 2013;11:756-60.

8. N Engl J Med. 2015;373:511-20.

9. Curr Opin Anaesthesiol. 2014;27:409-19.